BACKGROUND AND OBJECTIVES:Unruptured intracranial aneurysms (UIAs) are increasingly detected and require careful management to prevent rupture. No externally validated score currently predicts procedural risk to guide treatment decisions. We developed and validated 2 predictive scores for complications after endovascular treatment (EVT) or neurosurgical treatment (NT) of UIA using routinely collected clinical and aneurysmal features. METHODS:We conducted a multicenter retrospective study including patients with UIA treated with EVT or NT across 15 neurovascular centers (2014-2024). Predictive models were built using multivariable logistic regression, with variables derived from Delphi consensus. The primary outcome was a composite safety end point: new neurological deficits, modified Rankin Scale (mRS) worsening (≥1 point or mRS 2-5 within 30 days), or procedural death. Internal validation used bootstrapping, and external validation was performed temporally and institutionally. Model performance was assessed using area under the receiver operating characteristic curve (AUROC) and calibration. Final scores, named Morbidity and Mortality Associated Risk in the Treatment of UIAs (MARTA)-EVT and MARTA-NT, were compared with existing models identified through systematic review. RESULTS:Among 2647 patients (1907 EVT and 740 NT), procedural complications occurred in 6.3% (EVT) and 12.8% (NT). Independent predictors included age, baseline mRS, aneurysm location, size, morphology, and procedural factors. MARTA-EVT (AUROC = 0.68, 95% CI = 0.57-0.78) and MARTA-NT (AUROC = 0.65, 95% CI = 0.54-0.77) showed moderate discrimination and good calibration. MARTA-EVT outperformed existing models; MARTA-NT performed similarly to SAFETEA. Predictive models are available open-source: https://martascoreapp.shinyapps.io/martascoreapp/ . CONCLUSION:MARTA-EVT and MARTA-NT are validated tools for predicting procedural risks in UIA treatment and may support patient counseling and clinical decision making.

Tandem occlusions represent one of the most challenging scenarios in endovascular treatment of acute ischemic stroke.1-4 Management of extracranial occlusion is technically demanding, especially when located at the level of the brachiocephalic trunk. We report 2 cases of tandem lesions due to a brachiocephalic trunk. In the first, a distal hemodynamic occlusion was treated with a side-by-side Wallstent (Boston Scientific), in the common carotid artery and subclavian artery, after unsuccessful thrombectomy using a double stent and a 0.88-inch-long sheath. In the second, a tandem lesion with M1 occlusion and stenosis at the origin of the brachiocephalic trunk was approached retrogradely to recanalize the M1, followed by a combined antegrade-retrograde strategy to treat the trunk. These cases illustrate the need for technical flexibility and adaptation, often requiring devices from peripheral or cardiology fields. Our experience underscores the importance of tailored endovascular strategies in managing complex extracranial occlusions associated with tandem lesions.

INTRODUCTION/OBJECTIVE:Acute intracranial stenting during endovascular thrombectomy (EVT) for ischemic stroke requires intraprocedural antiplatelet therapy (APT) to maintain patency. However, the hemorrhagic risk of combining APT with intravenous thrombolysis (IVT) remains uncertain. We evaluated the safety of IVT combined with conservative versus aggressive intraprocedural APT in patients requiring stenting during EVT. METHODS:This multicenter RESISTANT registry subanalysis (2016-2023) included 823 adults. APT was categorized as conservative (aspirin +/- oral P2Y12) or aggressive (including GPIIb/IIIa inhibitors or cangrelor). The primary outcome was a composite of symptomatic intracranial hemorrhage (sICH) and parenchymal hematoma (PH1/PH2). Multivariable logistic regression assessed associations and interactions between IVT and APT. RESULTS:A total of 823 patients were included: 44 (5.3%) received IVT + conservative APT, 130 (15.8%) No IVT + conservative APT, 145 (17.6%) IVT + aggressive APT, and 504 (61.2%) No IVT + aggressive APT. Frequencies of sICH-PH1-PH2 were 9.3% with IVT + conservative APT, 10.7% with IVT + aggressive APT, 3.2% with No IVT + conservative APT, and 9.9% with No IVT + aggressive APT. In multivariable analysis without interaction terms, neither IVT (aOR 1.18, 95% CI 0.58-2.27; p = 0.64) nor aggressive APT (aOR 2.10, 95% CI 0.92-5.69; p = 0.10) was independently associated with increased risk of sICH-PH1-PH2. However, in the interaction model, IVT within the conservative-APT stratum (aOR 5.84, 95% CI 1.07-43.92; p = 0.05) and aggressive APT within the no-IVT stratum (aOR 4.81, 95% CI 1.41-30.22; p = 0.03) were each associated with higher odds of sICH-PH1-PH2, while the IVT-by-APT interaction term was < 1 (aOR 0.15, 95% CI 0.02-0.94; p = 0.05), indicating attenuation of the joint effect on the multiplicative odds scale. CONCLUSION:Among patients requiring intracranial stenting during EVT, we found no evidence that IVT and aggressive intraprocedural APT act synergistically to increase hemorrhagic risk. Rather, the negative IVT-by-APT interaction suggested attenuation of the joint effect on the multiplicative odds scale, although patients receiving both therapies remained at increased hemorrhagic risk relative to the reference group.

INTRODUCTION:Intrasaccular flow disrupters (IFDs) are increasingly used in endovascular management of intracranial wide neck bifurcation aneurysms (WNBAs). The next generation Saccular Endovascular Aneurysm Lattice (SEAL) system is a self-expanding, dual layered, braided nitinol IFD available in two configurations (SEAL Arc and SEAL Base) without a lead-in marker band. This primary subgroup analysis of the Pre-SEAL First-in-Human Interventional Trial (Pre-SEAL IT; NCT05686733) reports the final clinical and angiographic outcomes of the SEAL system in the management of WBNAs before the investigational device exemption (IDE) pre-marketing approval US based pivotal trial. METHODS:Pre-SEAL IT is a prospective, multicenter, single arm study, with US based independent imaging core lab adjudication. Primary safety endpoints were major periprocedural stroke, new subarachnoid hemorrhage, or neurologic death up to 12 months. Primary efficacy endpoints were complete (Raymond-Roy occlusion classification (RROC) 1 Woven EndoBridge occlusion scale (WOS) A or RROC 1 WOS B) or adequate occlusion (RROC 1 WOS A, RROC 1 WOS B, or RROC 2 WOS C) without parent artery compromise at 12 months. RESULTS:13 WNBA aneurysms in 13 patients meeting similar inclusion and exclusion criteria to the Woven EndoBridge Intrasaccular Therapy (WEB-IT) IDE pivotal trial were included in this primary subgroup analysis. Technical success (device delivered and deployed as intended) was 100% (13/13). There were no major periprocedural strokes, new subarachnoid hemorrhages, or neurologic deaths. Independent core lab adjudication showed 11/13 patients (84.6%) achieved complete occlusion and 12/13 patients (92.3%) achieved adequate occlusion at 12 month follow-up. CONCLUSIONS:SEAL intrasaccular flow disruption showed high technical success, an acceptable safety profile, and encouraging 12 month occlusion rates in the treatment of WNBAs.

Introduction: Endovascular treatment (EVT) in combination with best medical management for the treatment of distal/medium vessel occlusion (DMVO) stroke failed to improve disability-related outcomes and was associated with a trend toward worse safety outcomes in three randomized controlled trials (RCTs) recently presented. Our aim was to compare baseline clinical characteristics of patients with DMVO stroke treated in routine clinical practice with those of patients enrolled in RCTs. HYPOTHESIS: The baseline clinical characteristics of patients included in RCTs differ from those of patients treated outside of RCTs. Methods: We conducted a retrospective comparative study using a prospectively recorded, dual-center, database of patients. We included all consecutive patients with an AIS due to isolated primary DMVO (distal or non-dominant M2, M3, A2, A3, P1, P2) who underwent EVT and/or were randomized into a distal occlusion clinical trial from January 2022 to July 2024. Patients were categorized as receiving EVT under routine clinical practice (RP group) or enrolled in a randomized clinical trial for DMVO stroke (clinical trial, CT group). Results: A total of 182 patients with an AIS due to isolated DMVO were included: median age was 79 (IQR 69-86) years, 84 (46.2%) patients were female, and the median baseline mRS was 1 (IQR 0-2). Fifty-three patients (29.1%) were in the CT group, and 129 (70.9%) in the RP group. CT patients showed a trend toward longer time from symptom onset to imaging (431 [IQR 150-630] minutes vs 265 [100-606]; p=0.149), presented lower baseline NIHSS score (5 [4-7] vs 10 [7-15]; p<0.001), higher cumulative vascular risk (41.5% vs 24.6% in RP group, p=0.024), and lower median hypoperfusion volume (Tmax<6s) on admission CTP (27 [16-42] vs 48 [24-70] p<0.001). CONCLUSIONS: Our study highlights potential selection bias in RCTs involving DMVO stroke, with trial patients presenting less severe strokes than those treated in routine clinical practice. These differences may limit the generalizability of RCT findings and emphasize the need for more representative trial designs.

Background Rapid identification of large vessel occlusion (LVO) in acute ischemic stroke (AIS) is essential for reperfusion therapy. Screening tools, including Artificial Intelligence (AI) based algorithms, have been developed to accelerate detection but rely heavily on pre-test LVO prevalence. This study aimed to review LVO prevalence across clinical contexts and analyze its impact on AI-algorithm performance.Methods We systematically reviewed studies reporting consecutive suspected AIS cohorts. Cohorts were grouped into four clinical scenarios based on patient selection criteria: (a) high suspicion of LVO by stroke specialists (direct-to-angiosuite candidates), (b) high suspicion of LVO according to pre-hospital scales, (c) and (d) any suspected AIS without considering severity cut-off in a hospital or pre-hospital setting, respectively. We analyzed LVO prevalence in each scenario and assessed the false discovery rate (FDR) - number of positive studies needed to encounter a false positive, if applying eight commercially available LVO-detecting algorithms.Results We included 87 cohorts from 80 studies. Median LVO prevalence was: (a) 84% (77-87%), (b) 35% (26-42%), (c) 19% (14-25%), and (d) 14% (8-22%). At high prevalence levels: (a) FDR ranged between 0.007 (1 false positive in 142 positives) and 0.023 (1 in 43), whereas in low prevalence scenarios (Ccand d), FDR ranged between 0.168 (1 in 6) and 0.543 (over 1 in 2).Conclusion To ensure meaningful clinical impact, AI algorithms must be evaluated within the specific populations and care pathways where they are applied.

Introduction Hypothermia is considered a promising adjunctive neuroprotective therapy to reduce brain injury following large-vessel occlusion (LVO) stroke and reperfusion. With current cooling approaches that are limited by slow onset, procedural complexity, systemic adverse effects, and insufficient reduction in brain temperature, endovascular intra-arterial infusion of cold fluids (IAIC) has emerged as a more efficient method to achieve local brain hypothermia. However, technologies for IAIC to be performed in a controlled and thermally efficient way have been lacking. Methods In this first-in-human investigational device study (single-center, prospective, single-arm), we investigated the safety, feasibility, and technical performance of an IAIC brain cooling system (ΔH System, Hybernia Medical, New York, USA). Patients with anterior circulation LVO stroke underwent standard-of-care reperfusion therapy followed by selective brain cooling with the ΔH System. Target hypothermia level was a local temperature reduction by 4°C for up to 30 min. Results In a total of five patients (median age 74 years (range 68–86); baseline National Institutes of Health Stroke Scale (NIHSS) 20 (11–23)) target arterial input temperature was achieved in 37±15 s and maintained within ±1°C. Systemic temperature and laboratory values remained stable overall and no device-related adverse events were observed. Median NIHSS was 7 at 24 hours and 6 at discharge. There was one occurrence of an asymptomatic hemorrhagic infarction type 2, and one patient died on day 27 (pneumonia unrelated to investigational procedure). At 90 days, 60% achieved excellent functional outcome (modified Rankin Scale 0). Conclusions These results suggest that selective cerebral hypothermia with the ΔH System after mechanical thrombectomy is safe and feasible. Further studies are warranted. Trial registration number NCT06634303 .

BACKGROUND:Randomized trials have not shown a clear benefit of endovascular therapy (EVT) for medium vessel occlusion (MeVO) strokes. We aimed to identify subgroups in which successful recanalization provides meaningful clinical benefit. METHODS:We retrospectively analyzed prospectively recorded consecutive patients with MeVO stroke treated with EVT at two comprehensive stroke centers. Successful recanalization was defined as expanded Thrombolysis in Cerebral Infarction (eTICI) 2b-3. The treatment effect was calculated as the difference in 90-day functional independence (modified Rankin Scale score 0-2) between recanalized and non-recanalized patients. Predicted infarct core on admission was calculated on non-contrast CT using AI-based software (AI-ICV; Methinks AI) and on CT perfusion (cerebral blood flow (CBF) <30%; IschemiaView). The hypoperfused volume (Tmax >6 s) was also obtained and the perfusion mismatch ratio was calculated (Tmax >6 s - CBF <30%)/Tmax >6 s). The treatment effect was analyzed in the overall cohort and after applying enrichment strategies based on clinical and imaging variables. Optimal cutoffs were identified by maximizing the added treatment effect while retaining ≥40% of the cohort. RESULTS:Among 232 EVT-treated patients (mean age 76.1±12.3 years; median (IQR) National Institutes of Health Stroke Scale (NIHSS) score 9 (6-14)), the recanalization rate was 84.9%. The overall treatment effect was +33.3% (recanalized 53.3% vs non-recanalized 20.0%). Enrichment strategies increased the treatment effect: age ≤80 years (+13.8%), AI-ICV ≤9 mL (+9.9%), and NIHSS score ≥10 (+6.7%). Combining age, NIHSS, and AI-ICV criteria increased the treatment effect to 61.9% for an added value of +33.6%. CONCLUSIONS:In MeVO stroke, the benefit of successful recanalization is substantial and can be further enhanced through pragmatic enrichment using readily available clinical and imaging variables, supporting refined patient selection and future trial design focused on enriched subgroups.

INTRODUCTION:The optimal endovascular treatment strategy for medium and distal vessel occlusions remains undefined given the anatomical challenges of distal vessels. Stent retriever-assisted intra-arterial lysis (SAIL) is a pharmacomechanical technique designed to facilitate clot dissolution while minimizing mechanical stress on fragile distal vessels. METHODS:We performed a retrospective single-center analysis of consecutive patients with acute ischemic stroke due to distal vessel occlusions treated with SAIL between November 2022 and January 2026. Distal occlusions included M2-M3, A2-A3, and P1-P2 segments, and were classified as primary or secondary. SAIL consisted of temporary stent retriever deployment across the thrombus to restore flow, followed by intra-arterial tirofiban infusion through a distal access catheter and subsequent device resheathing. Primary outcomes were feasibility and safety; secondary outcomes included angiographic reperfusion and clinical outcomes. RESULTS:24 patients were included (mean age 74±14.6 years; median baseline National Institutes of Health Stroke Scale (NIHSS) 16). Most occlusions involved the middle cerebral artery territory (79.2%). SAIL was predominantly used after unsuccessful mechanical thrombectomy (70.8%), with a median of two prior device passes. Successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) was achieved in 87.5% of patients, including near-complete or complete reperfusion (mTICI 2c-3) in 62.5%. Any intracranial hemorrhage occurred in 25.0% of patients and symptomatic intracranial hemorrhage in 4.2%. At 90 days, functional independence (modified Rankin Scale 0-2) was observed in 6 of 12 patients (50%) with available follow-up. CONCLUSIONS:SAIL was feasible and achieved high reperfusion rates with a low rate of symptomatic intracranial hemorrhage despite frequent use as rescue therapy after failed thrombectomy. These findings support further evaluation of pharmacomechanical strategies for distal vessel occlusions.

Brain delivery remains a challenge for the clinical translation of therapeutic nanomedicines, particularly in focal diseases with specific delivery needs, such as stroke. In this scenario, clinically relevant endovascular interventions are recently being proposed as strategies to enhance delivery into specific cerebral vascular territories. In this study, we assess the feasibility of endovascular delivery and magnetic retention of biocompatible magnetic nanocapsules (NCs) in cerebral circulation models that better predict human responses. More specifically, polymeric NCs synthesized with magnetic properties (superparamagnetic oxide nanoparticles, SPIONs) and fluorescent (Cy5) moieties were infused into pigs via a femoral microcatheter reaching the brain vasculature and showing greater efficacy in targeting the ipsilateral brain hemisphere with preferential accumulation in microvessels when compared to intravenous administration which resulted in very little accumulation. Transient adverse effects related to hemodynamic instability upon nanocapsule administration were observed in both administration groups related to acute complement activation. Successful endovascular brain NC delivery is further demonstrated in a 3D-vascular model of the human large arterial vessel brain supply, with successful NC accumulation in the target arterial segment (the proximal middle cerebral artery) with sensible enhancement when using local magnetic fields. This study demonstrates the feasibility of endovascular NC delivery for focal brain nanotargeting via clinically relevant and minimally invasive procedures and proves the advantages of using magnetized nanomaterials to improve local vascular NC retention. Further safety and efficacy studies, including drug nanocapsule formulations, are needed to establish the clinical relevance of the proposed approach.

Background Intrasaccular devices have broadened treatment options for wide necked aneurysms. This study presents the preliminary experience with the Artisse 2.0 device.Methods Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE) is a non-randomized, multicenter, real world clinical study with treatment arms for aneurysms (INSPIRE-A) and acute ischemic stroke (INSPIRE-S). This interim analysis included 87 patients enrolled from November 2022 to April 2024 in the INSPIRE-A Artisse cohort across 16 Europoean centers. Procedures followed standard clinical care, with 6 months of follow-up. Safety and efficacy endpoints included major stroke, neurological death, serious adverse events (SAEs), aneurysm occlusion, and retreatment rates. An independent core laboratory assessed imaging, and all SAEs were reviewed by a clinical events committee. The Artisse steering committee provided independent oversight of the data.Results The Artisse device achieved an overall successful implantation rate of 96.6% (84/87), with satisfactory placement rates of 98.7% (74/75) for unruptured and 88.9% (8/9) for ruptured aneurysms. Following the procedure, 46.2% of unruptured aneurysm patients were receiving antiplatelet therapy (APT), predominantly aspirin monotherapy, while no ruptured aneurysm patients received APT. Device related SAE rate was 1.3% (1/87), and the overall stroke rate was 2.3% (2/87), including both ruptured and unruptured aneurysms. At 6 months, 80.0% (28/35) of patients with unruptured aneurysms showed complete obliteration, with no recurrences or retreatments.Conclusions Preliminary experience with the Artisse 2.0 device demonstrated high technical success, favorable safety, and efficacy in aneurysm obliteration at 6 months. Larger studies with longer follow-up periods are needed to confirm these findings.

Introduction: Intracranial stenting during endovascular thrombectomy (EVT) is a common practice in the setting of failed reperfusion or severe stenosis. Immediate stent patency requires periprocedural antiplatelet therapy (APT). How APT intensity interacts with prior intravenous thrombolysis (IVT) to influence hemorrhagic risk remains uncertain. We aimed to assess whether the APT regimen modifies the association of IVT with early intracranial hemorrhage after intracranial stenting during EVT. Methods: This was a subanalysis of the RESISTANT registry, a multicenter, international, retrospective cohort (2016 to 2023) of adults with acute ischemic stroke who underwent intracranial stenting during EVT. APT regimens were categorized as conservative (intravenous or oral aspirin alone, or aspirin plus an oral P2Y12 inhibitor) and aggressive (any regimen including intravenous GPIIb/IIIa inhibitor or intravenous cangrelor). Four main groups were compared according to the APT regimen (conservative/aggressive) and the use of IVT (+/-). The primary outcome was a composite of sICH and parenchymal hematoma types 1 and 2 (sICH-PH2-PH1). Multivariable logistic regression models were used to evaluate the interaction between IVT and APT, adjusting for clinically relevant covariates. Results: Among the 823 included patients, 44 (5.3%) received conservative APT with IVT, 130 (15.8%) received conservative APT without IVT, 145 (17.6%) received aggressive APT with IVT, and 504 (61.2%) received aggressive APT without IVT. Among patients who received IVT, sICH-PH2-PH1 rates were 9.3% with conservative APT and 10.7% with aggressive APT; among those without IVT, rates were 3.2% and 9.9%, respectively. Administration of IVT (adjusted odds ratio [aOR] 5.84, 95%CI 1.07 to 43.92; p=0.05) and aggressive APT (aOR 4.81, 95% CI 1.41 to 30.22; p=0.03) were each associated with higher odds of hemorrhagic complications, with a significant IVT by APT interaction (P interaction =0.05; Figures 1 and 2 ). Within the aggressive APT plus IVT subgroup, sICH-PH2-PH1 occurred in 20% of patients treated with cangrelor and 6.1% treated with a glycoprotein IIb/IIIa inhibitor ( Figure 3 ). Conclusion: Among patients requiring intracranial stenting, aggressive periprocedural APT and prior IVT are each associated with higher hemorrhagic risk, with the combination showing the worst observed crude outcome. Prospective evaluation of protocolized APT pathways in the IVT setting is warranted.

BACKGROUND AND AIM:Acute intracranial stenting is increasingly used as a rescue strategy during endovascular treatment for large vessel occlusion strokes. Limited data exist regarding the risk, clinical relevance, and optimal management of hemorrhagic transformation (HT) in this context. We aimed to evaluate the incidence, predictors, outcomes, and post-interventional antiplatelet management of HT in an international multicentric registry. METHODS:We analyzed data from the RESISTANT registry, including patients who underwent emergent intracranial stenting for acute stroke between 2016 and 2023. Two complementary analyses were performed: (1) characterization of HT subtypes and associated outcomes (NIHSS at discharge, mortality, and mRS at discharge and 90 days) and (2) evaluation of antiplatelet management after Heidelberg class-1 HT detection and its impact on stent occlusion, hemorrhage progression, in-hospital mortality, and 90-day mRS. RESULTS:Among 809 patients included, 177 (22%) experienced HT, of which 63 (8%) were symptomatic intracranial hemorrhage. Parenchymal hematomas (PH-1 and PH-2) and HI-2 were associated with worse functional outcomes and higher mortality. In the post-HT management cohort (n = 117), use of a high-intensity antiplatelet regimen (dual oral antiplatelet or any intravenous agent) was associated with lower risk of stent occlusion (adjusted risk ratio (aOR) = 0.21 [0.05-0.86]) and in-hospital mortality (aOR = 0.08 [0.01-0.50]) without increased hemorrhagic progression (0.52 [0.09-3.07]). CONCLUSION:HT remains a relevant complication after emergent intracranial stenting, particularly in patients with parenchymal hematoma. High-intensity antiplatelet therapy appears safe in select HT subtypes and was linked to reduced occlusion and mortality.

The temporal evolution of non-contrast CT (NCCT) markers of intracerebral hemorrhage (ICH) expansion during the dynamics of acute ICH is understudied. We aimed to evaluate the temporal evolution of these markers and its relationship with ICH dynamics. Single-center, prospective, observational cohort study on 271 ICH patients < 6 h. Patients underwent baseline NCCT and multiphase CTA, and 24-hour NCCT. NCCT markers included: irregular shape, satellite sign, and island sign (shape markers); heterogeneous density, hypodensities, swirl sign, black hole sign, blend sign, and fluid level (qualitative density markers); and mean, standard deviation, and coefficient of variation hematoma density (quantitative density markers). The spot sign in first phase of multiphase CTA was considered marker of active hemorrhage. Primary outcome was the change in frequency or values of NCCT markers from baseline to follow-up NCCT. Other outcomes included associations of active hemorrhage with NCCT markers at baseline and with the magnitude of their change at follow-up NCCT. Heterogeneous density predicted active hemorrhage with the highest accuracy (66.4

Abstract Background and aims The role of endovascular treatment (EVT) for medium and distal vessel occlusions (MeVO) remains uncertain after recent randomized trials failed to show clinical benefit and raised safety concerns. Stent-retriever–assisted intra-arterial lysis (SAIL) is a pharmacomechanical technique designed to enable distal reperfusion while minimizing mechanical stress on fragile vessels. We evaluated feasibility, safety, and outcomes of SAIL in distal vessel occlusions. Methods We performed a retrospective single-center analysis of consecutive acute ischemic stroke patients with angiographically confirmed distal vessel occlusions treated with SAIL between March 2022 and January 2026. Occlusions involved M2–M3, A2–A3, or P1–P2 segments and were classified as primary or secondary. SAIL consisted of temporary stent retriever deployment across the thrombus to restore flow, combined with slow intra-arterial infusion of tirofiban or alteplase, followed by resheathing without traction. Primary outcomes were feasibility and safety, including symptomatic intracranial hemorrhage (sICH). Secondary outcomes included angiographic reperfusion and clinical outcomes at discharge and 90 days. Results Twenty-four patients were included (mean age 75.5 years; median baseline NIHSS 11). SAIL was used as rescue therapy after unsuccessful mechanical thrombectomy in 70.8%. Successful reperfusion (mTICI ≥2b) was achieved in 83.3%, with near-complete or complete reperfusion in 50.0%. Any intracranial hemorrhage occurred in 29.2%, while sICH occurred in one patient (4.2%). At 90 days, functional independence (mRS 0–2) was achieved in 52.4% of evaluable patients. Conclusions SAIL was feasible and associated with high distal reperfusion rates and low sICH. Findings support further prospective evaluation in selected distal vessel occlusions and clinical practice. Conflict of interest

BACKGROUND AND PURPOSE:Mechanical thrombectomy (MT) is the standard of care for acute ischemic stroke (AIS) due to large vessel occlusion (LVO), but the optimal combination of devices remains under investigation. The Safety and Efficacy of the Overall Thrombectomy System for Stroke (SEMTiC-01) trial evaluates the safety and efficacy of a novel, fully integrated neurothrombectomy system composed of the iNedit balloon distal access catheter, the iNdeep microcatheter, and the iNtercept stent retriever. MATERIALS AND METHODS:SEMTiC-01 is a prospective, multicenter, single-arm, open-label trial conducted across 18 centers in Spain, Germany, and Belgium. A total of 175 patients with LVO stroke were enrolled and treated within 24 hours of symptom onset. The primary efficacy end point was the rate of successful reperfusion (expanded Thrombolysis in Cerebral Infarction [eTICI] score ≥2b) in ≤3 passes. The primary safety end points included serious adverse events within 24 hours and 90-day mortality. Secondary end points included good functional outcome (mRS 0-2 at 90 days), early neurologic improvement, and device navigability. RESULTS:Successful reperfusion was achieved in 75.4% of the intention-to-treat (ITT) and 83.6% of the per-protocol (PP) population. Good functional outcomes were observed in 55.8% (ITT) and 56.9% (PP), and rapid neurologic improvement in 64.6% of patients. First-pass reperfusion (eTICI ≥2b) was obtained in 46.9% (ITT) and 51.4% (PP). Symptomatic intracranial hemorrhage occurred in 1.7% (ITT), and mortality at 90 days was 13.7%. Device navigability was rated good in more than 75% of cases for both iNedit, iNtercept, and iNdeep. Balloon inflation during thrombectomy improved outcomes in M1 occlusions. CONCLUSIONS:The triad system (iNedit, iNdeep, and iNtercept) demonstrates noninferiority compared with published literature, with favorable safety and efficacy profiles. Its favorable navigability suggests it is a promising option for MT in AIS.

Abstract Background and aims Despite advances in reperfusion therapies, many stroke patients remain with disability. Additional neuroprotective strategies are needed to reduce brain injury following ischemia and reperfusion. Hypothermia is considered the most effective adjunctive neuroprotective therapy; however, current cooling approaches are limited by slow onset, procedural complexity, and systemic adverse effects.Hybernia Medical has developed an endovascular intra-arterial brain cooling system that enables rapid and selective cerebral hypothermia through controlled, automated infusion of cold saline. This First-in-Human study evaluated the safety, feasibility, and technical performance of the Delta (Δ) H Brain Cooling System. Methods Single-arm study:anterior-circulation stroke patients received selective brain-cooling with ΔH-system immediately after EVT. Target hypothermia was a brain temperature reduction of 4°C for up to 30 minutes. Safety endpoints included intracranial imaging findings, neurological deterioration, and laboratory abnormalities. Clinical outcomes were assessed using NIHSS (24h and discharge), and modified Rankin Scale (mRS) at 30+90 days. Results Five patients underwent the cooling protocol. Mean infused saline volume was 885±330 mL. Target temperature was achieved within 37±15 seconds and maintained within ±1°C. Systemic temperature and hematocrit remained stable. One patient developed asymptomatic HI-2, considered part of natural post-reperfusion course. Early neurological improvement occurred in 4/5 patients. All patients were discharged. One patient died on day 27 from pneumonia unrelated to the procedure. At 90 days, 60% achieved mRS 0–2. Conclusions These results suggest that selective cerebral hypothermia with the ΔH system after mechanical thrombectomy is safe and feasible. Further studies are warranted, and a multicenter pilot trial is planned. Conflict of interest Marc Ribo: Nothing to disclose, Marc Rodrigo-Gispert: Nothing to disclose, Manuel Requena: Nothing to disclose, Marta de Dios: Nothing to disclose, Francesco Diana: Nothing to disclose, David Hernandez: Nothing to disclose, Alejandro Tomasello: Nothing to disclose, Marta Rubiera: Nothing to disclose, John Pile-Spellman: Hybernia, Jae H. Choi: Hybernia

INTRODUCTION:Timely transfer of patients with suspected LVO remains critical in acute stroke systems. Artificial intelligence (AI)-based imaging tools are increasingly implemented to support triage in non-thrombectomy centres. We assessed whether integrating an AI algorithm within established tele-stroke centres reduces time to transfer decision. PATIENTS AND METHODS:We conducted a prospective, multicentre, quasi-experimental study comparing consecutive cohorts in 2 tele-stroke centres referring to a single comprehensive stroke centre, before and after implementation of the Methinks Stroke Suite, an AI algorithm for LVO detection on non-contrast CT (NCCT) and CTA. Consecutive transferred patients with suspected acute ischaemic stroke were included. Remote vascular neurologists retained responsibility for final transfer decisions. Each phase spanned approximately 15 months. The primary outcome was time from arrival at the local centre to emergency medical services activation. Secondary outcomes included workflow intervals, imaging utilisation and algorithm performance. RESULTS:We included 265 patients (136 in the post-implementation cohort; 129 in the pre-implementation cohort). Adjusted median time from arrival to transfer request did not differ (median difference - 2.40 min; 95% CI, -6.16 to 4.48). Post-implementation, time from imaging to transfer request (-7.16 min; 95% CI, -13.02 to -1.85) and arrival to groin puncture (-31.28 min; 95% CI, -60.89 to -13.74) decreased. Computed tomography angiography acquisition at referring centres increased (28%-81%), reducing repeat imaging at the comprehensive centre (79%-42%). Non-contrast CT-based AI prediction yielded a positive predictive value of 66% for endovascular treatment. CONCLUSION:Artificial intelligence implementation was not associated with a shorter time to transfer decision. Fewer redundant imaging examinations were associated with a shorter time to reperfusion.

BACKGROUND:Super-large-bore aspiration catheters are designed to improve clot engagement and aspiration efficiency during mechanical thrombectomy. However, multiple 0.088-inch platforms are now available, and device-specific clinical performance cannot be inferred from catheter size alone. We report the first multicenter real-world experience with SOFIA 88. METHODS:This retrospective multicenter European registry included consecutive patients treated with SOFIA 88 for anterior circulation large vessel occlusion involving the internal carotid artery or M1. The primary outcome was successful catheter advancement to the thrombus-vessel interface. Angiographic outcomes included first-pass effect (extended Thrombolysis in Cerebral Infarction (eTICI)≥2c after one pass), final complete reperfusion (eTICI 2c-3), and final successful reperfusion (eTICI≥2b). Safety outcomes included procedural complications, embolization to new territory, intracranial hemorrhage, and symptomatic intracranial hemorrhage. RESULTS:Eighty-one patients from eight centers were included. SOFIA 88 reached the thrombus-vessel interface in 67/81 cases (82.7%), most often using smaller-catheter support (57/81, 70.4%). SOFIA 88 standalone first-pass effect occurred in 32/81 patients (39.5%) using the full real-world cohort denominator and in 32/67 patients (47.8%) among cases with successful SOFIA 88 target access. Final complete and successful reperfusion was achieved in 67/81 (82.7%) and 79/81 (97.5%) patients, respectively. Procedural adverse events occurred in 3/81 (3.7%), embolization to new territory in 1/81 (1.2%), and symptomatic intracranial hemorrhage in 5/81 (6.2%). No device-related adverse events occurred. CONCLUSIONS:SOFIA 88 showed feasible target access, high final reperfusion, favorable standalone first-pass performance after successful target access, and acceptable early safety. Further prospective studies are warranted to define optimal patient selection, delivery strategies, and the role of SOFIA 88 in contemporary thrombectomy practice.