Stenosis within the arteriovenous fistula (AVF) of hemodialysis patients leads to vascular access dysfunction and inadequate hemodialysis. Percutaneous transluminal angioplasty (PTA) is the standard therapy for stenosis. However, rates of restenosis and loss of access patency remain high. Outcomes of a novel cell-impermeable endoprosthesis (CIE) have not been investigated in this setting. Therefore, our study was designed to address this as a prospective, international, multicenter pivotal trial (NCT04540302) with 245 patients with stenosis in their venous outflow circuit randomized to treatment: 122 receiving CIE and 123 receiving PTA across 43 international centers. Primary endpoints included target lesion primary patency (TLPP) at six months (freedom from clinically driven target lesion revascularization or target lesion thrombosis) and freedom from safety events through 30 days post-index procedure that affected the access circuit and resulted in reintervention, hospitalization, or death. Access circuit primary patency (ACPP) was evaluated as a secondary efficacy endpoint. Six-month TLPP and ACPP were significantly higher for the CIE cohort versus PTA (TLPP: 89.6% vs. 62.3%; ACPP: 72.2% vs. 57.0%). Thirty days post-index procedure, there was no statistically significant difference in the freedom from safety events for the CIE versus PTA (96.6 vs. 95.0%). No differences were observed in adverse events between either cohort. Our study shows that among patients with stenosis in their AVF, the CIE was superior to PTA with respect to six-month TLPP and ACPP with no observed difference in 30-day primary safety events.

Objective: There are varying anatomical and mechanical demands of stent placement in the iliofemoral venous segment; the Duo Venous Stent System is designed to address these issues. The purpose of the VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) study was to investigate the safety and efficacy of the Duo Venous Stent System for the treatment of patients with nonmalignant iliofemoral venous obstructive disease. Methods: This was an international, prospective, multicenter, single-arm study that enrolled patients with symptomatic non- thrombotic (NT), post-thrombotic (PTS), or acute deep vein thrombotic (aDVT) iliofemoral venous outflow obstruction. The primary safety end point was freedom from major adverse events at 30 days after the index procedure. The primary efficacy end point was primary patency of stent-bearing segments at 12 months. Secondary and observational end points included symptom relief, primary-assisted patency, secondary patency, and device success. Patients remain in follow-up for 36 months. Results: A total of 162 patients were enrolled at 30 sites in the United States and Poland. The primary safety end point was achieved in 98.7% of patients against a predefined performance goal of 89.0% (P < .0001). The primary safety end point was achieved in 100%, 95.0%, and 100% of the NT, PTS, and aDVT cohorts, respectively. The primary efficacy end point was met in 90.2% compared with the performance goal of 77.3% (P 1/4 .0002). Primary patency was observed in 95.2% of patients with NT disease, 79.4% of those with PTS, and 86.7% of those with aDVT. No stent fracture, migration, or embolization occurred through 12 months. Patient-reported outcomes showed improvements in Venous Clinical Severity Score, Villalta, EQ-5D-3L, and VEINES-QoL/Sym scores from baseline through 6 and 12 months. Conclusions: Through 12 months, the Duo Venous Stent System is safe and effective for the treatment of nonmalignant iliofemoral venous obstructive disease. (J Vasc Surg Venous Lymphat Disord 2025;13:101995.) Clinical Relevance: The VIVID (Venous stent for the Iliofemoral Vein Investigational clinical trial using the Duo Venous Stent System) investigational device exemption trial is the first study of a hybrid, venous stent specifically designed to address the anatomic challenges of the iliofemoral venous system. The Duo Venous Stent System consists of a self- expanding nitinol Duo Hybrid Stent used independently or in conjunction with the flexible extension Duo Extend Stent. This is the first report of primary outcomes from the VIVID Study, assessing the safety and efficacy of the Duo Venous Stent System to treat patients with nonmalignant, symptomatic iliofemoral venous outflow obstruction. The Duo Venous Stent System successfully met its 12-month safety and effectiveness performance goals.

OBJECTIVE:This first in human study evaluated the six month angiographic and one year clinical outcomes of a novel thin strut, sirolimus eluting, resorbable scaffold for symptomatic below knee peripheral arterial disease (PAD). RESOLV I is an international, prospective, multicentre, single arm study assessing the performance of the MAGNITUDE drug eluting resorbable scaffold (DRS) for the treatment of below knee lesions in patients with symptomatic PAD. METHODS:Angiographic and duplex ultrasound evaluations were performed by independent core labs at baseline, post-DRS implantation, and at six months follow up. Binary re-stenosis (> 50% diameter stenosis) was determined via quantitative vascular angiography or duplex ultrasound when quantitative vascular angiography was unavailable. Peri-operative death, major adverse limb events, and functional status were evaluated up to one year. RESULTS:Thirty five patients (mean age 74.5 ± 6.0 years) were enrolled: six (17%) had chronic total occlusion lesions and 25 (71%) had a baseline Rutherford-Becker classification of stage 5. The mean lesion length was 30.1 ± 12.0 mm. The binary re-stenosis rate at 6 months was 10% (3/31) (angiographic patency of 90%) and mean in segment late lumen loss was 0.75 ± 0.74 mm. Improved Rutherford class at 12 months follow up was achieved in 88% (29/33) of patients and most were asymptomatic (Rutherford-Becker class 0). No amputation or clinically driven target lesion revascularisation events were seen through 12 months. CONCLUSION:Early results of the RESOLV I study showed that implantation of a thin strut MAGNITUDE DRS achieved low binary re-stenosis rates at six months, as well as improvement in functional status, with no clinically driven target lesion revascularisation at one year.

Purpose: To present the results of the Liquid Embolization of Arterial Hemorrhages in Peripheral Vasculature (LAVA) study evaluating safety and effectiveness of Lava Liquid Embolic System, an ethylene vinyl alcohol (EVOH), for peripheral arterial hemorrhage (PAH). Materials and Methods: LAVA was a pivotal, prospective, multicenter, single-group, centrally adjudicated study of adults with active PAH. Patients received EVOH at 1 of 2 viscosities, administered by experienced physicians. The primary safety endpoint was freedom from 30-day major adverse events (MAEs) defined as ischemia/infarction of target territory, non-target embolization, allergic reaction, and catheter breakage/entrapment. The primary effectiveness endpoint was 30-day clinical success defined as absence of bleeding from target lesion after embolization without need for emergency surgery, reembolization, or other target lesion reinterventions. The secondary endpoints included serious adverse events and mortality. Results: A total of 113 patients (mean age, 57.4 years [SD +/- 18.0; range, 18.0-93.0 years]; male, 63.7%) with 148 lesions were enrolled at 19 US centers. Targeted areas included the nongastrointestinal visceral arteries (31.1%), kidneys (26.3%), upper gastrointestinal (GI) (11.5%), lower GI (6.8%), and extremities (6.1%). Empiric embolization was performed for 20.9% of lesions. The primary effectiveness endpoint was achieved in 94.3% of lesions (95.3% of patients), exceeding the performance goal of 72%. Two target lesions treated with EVOH required subsequent re-embolization. No surgeries were performed for bleeding or ischemia. There were no MAEs reported per study definition. All-cause mortality rate at 30 days was 8.3%. Conclusions: The LAVA study suggests that EVOH is effective and can be safely used as an embolic agent for treatment of PAH.

OBJECTIVE:This retrospective, multicentre study aimed to assess the prognostic value of a proposed classification system for chronic venous obstruction (CVO) patients undergoing successful interventional procedures. METHODS:This study analysed data from 13 vascular centres, including 1 033 patients with CVO treated between 2015 - 2019. The patients were classified into five category types: 1 - non-thrombotic iliac vein lesion; 2 - CVO of iliac segment; 3 - CVO of iliofemoral segment above common femoral vein confluence; 4 - CVO of iliofemoral segment extending into the femoral vein (FV) or deep femoral vein (DFV); and 5 - CVO of iliofemoral segment involving both DFV and FV. Stent deployment, complications, and follow ups were evaluated. Uni- and multivariable analyses were performed to identify predictors of primary patency loss. RESULTS:The mean age of the patients was 44.0 ± 14.7 years, with 59.9% being women. A median of two stents was used for unilateral cases and five stents for bilateral cases. At twelve months follow up, primary patency rates for types 1 - 5 were 94.9%, 90.3%, 80.8%, 60.6%, and 39.4%, respectively. These rates were strongly correlated with the extent of CVO and showed significant differences between each type. Univariable analysis identified predictors of primary patency loss as the type of CVO, history of deep vein thrombosis, and the total number of stents. In the multivariable analysis, the significant independent predictors of primary patency loss were the type of CVO and the total number of stents. CONCLUSION:The proposed anatomical classification of iliofemoral CVO will help to predict intervention outcomes and facilitate comparison of stent outcomes in future studies. However, further evaluation and validation in prospective studies are needed to confirm the utility of this classification.

BACKGROUND:Preclinical studies have demonstrated that therapeutic ultrasound (TUS) increases perfusion in peripheral artery disease (PAD). This pilot study assessed the safety and effectiveness of a noninvasive TUS device in patients with advanced PAD. METHODS:A phased array of TUS transducers was fabricated on a wearable sleeve, designed to sonicate the posterior and anterior tibial arteries (and their collaterals) at the calf level. Twelve patients with PAD (Rutherford classes 3-5) were enrolled in a single-arm study in which they underwent 30-40 daily 90-minute TUS sessions to the diseased limb. Changes in pedal flow and tissue oxygenation (StO2) were measured by laser speckle and spatial frequency domain imaging, respectively. A subset of five patients underwent evaluation by laser Doppler, transcutaneous oximetry (TcPO2), and quality of life questionnaires (Vascular Quality of Life Questionnaire [VascuQoL] and the Walking Impairment Questionnaire [WIQ]). RESULTS:Eleven out of 12 enrolled patients completed the study. During 90-minute TUS sessions pedal flow improved by 180% (p < 0.001) on laser speckle imaging, and 18% (p = 0.12) on laser Doppler. Tissue oxygenation improved by 18% (p = 0.43) on TcPO2 and by 6% (p = 0.097) on StO2. After all sessions, tissue oxygenation improved by 17% (p = 0.020) on StO2, without significant changes in laser Doppler (+39%, p = 0.41) or TcPO2 (-3%, p = 0.70), which was largely in the normal range (56 ± 15 mmHg) at baseline. VascuQoL improved by 2.4 points (14%, p = 0.080) and WIQ improved by 8.2 points (11%, p = 0.053). CONCLUSIONS:TUS for patients with symptomatic PAD was safe and well tolerated. Most metrics of tissue perfusion and oxygenation improved, but future sham-controlled studies are needed and planned.

PurposeTo report 36-month outcomes and subgroup analysis of the ABRE Study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease.MethodsThe ABRE Study was a prospective, multicenter, non-randomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5±15.9 years and 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality of life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively.ResultsPrimary, primary-assisted and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8% and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the post-thrombotic syndrome group, and 97.1% in the non-thrombotic iliac vein lesion group through 36 months. The mean lesion length was 112.4±66.1 mm. There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets.ConclusionsResults from the ABRE study demonstrated sustained patency with a good safety profile following implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

BACKGROUND:The main aim of this article is to investigate the causes of technical failure during endovascular recanalization in patients with post-thrombotic syndrome with occluded iliofemoral veins and to suggest alternative techniques to improve outcomes in such challenging cases.METHODS:Between November 2015 and August 2020, 230 patients (274 limbs) treated in our institution with symptomatic chronic iliofemoral venous obstruction underwent endovascular recanalization with angioplasty and stent placement. Overall, the initial attempt was unsuccessful in 15 limbs. We retrospectively analyzed the basic demographic and health characteristics of the involved patients and evaluated the endovascular procedures and techniques that resulted in a successful second intervention.RESULTS:The first attempts at endovascular intervention were unsuccessful in 15 of the 274 limbs (5.4%). Failures were attributed to hostile groin areas in intravenous drug abusers caused by multiple punctures in six cases. In addition, five interventions failed due to prior surgery at the site of venous occlusion and in retroperitoneal space, three patients due to severe stent deformity, and one patient due to congenital venous aplasia. Of the 15 patients, 11 underwent a subsequent attempt that included six successful recanalizations. The mean follow-up time of the six patients with successful recanalization was 27 months (5-62 months). The primary, assisted primary and secondary patency rates were 83.3%, 100%, and 100%, respectively. The remaining five patients, in whom the second recanalization attempt failed, received conservative treatment.CONCLUSIONS:Recanalization failure is rare in chronic venous obstruction patients. Severe stent deformities have the lowest chance of successful second intervention. Patients with a hostile groin or prior open surgeries at the occlusion site may be considered for reintervention with a success rate of nearly 50%.

Purpose: To use safety and efficacy outcomes following treatment with percutaneous transluminal angioplasty (PTA) and/ or stent placement for thoracic central venous obstruction in hemodialysis-dependent patients to establish objective performance goals (OPGs). Methods: A systematic literature review and meta-analysis were conducted for articles published between January 1, 2000, and August 31, 2021. Efficacy outcomes included primary patency rates at 6 and 12 months, and safety outcomes included adverse events (AEs) categorized as access loss, procedure-related AEs, and serious AEs (SAEs). OPGs were derived from the upper and lower bounds of the 95% confidence intervals for primary patency and SAE rates. Results: Of 66 articles reviewed, 17 met the inclusion criteria (PTA, n = 4; stent placement, n = 5; PTA/stent, n = 8). The 6-and 12-month primary patency rates for PTA were 50.9% and 36.7%, respectively. Based on these findings, the proposed 6-and 12-month primary patency OPGs identifying superiority against PTA were 66.5% and 52.6%, respectively, and those for noninferiority were 39.0% and 25.7%, respectively. For stent placement, the 6-and 12-month primary patency rates were 69.7% and 47.9%, respectively. The proposed 6-and 12-month primary patency OPGs identifying superiority were 82.1% and 64.1%, respectively, and those for noninferiority were 59.3% and 35.8%, respectively. SAE rates for PTA and stent placement were 3.8% and 8.1%, respectively. Proposed safety OPGs for noninferiority versus superiority for PTA and stent placement were 10.1% versus 1.4% and 13.6% versus 4.8%, respectively.Conclusion: The OPGs derived from real-world studies of PTA and stent placement may serve as a benchmark for future interventions indicated for this patient population.

Objective: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO.Methods: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score.Results: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixtythree patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINESQoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p=.82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score.Conclusion: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points.

BACKGROUND:Iliofemoral venous obstruction is recognized with increasing frequency as the underlying cause of lower extremity symptoms including edema, pain, skin changes, and, in advanced cases, ulceration. This study sought to evaluate the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction.METHODS:The ABRE Study (A Multi-Center, Non-Randomized Study to Evaluate the Safety and Effectiveness of the Abre Venous Self-Expanding Stent System in Patients With Symptomatic Iliofemoral Venous Outflow Obstruction) is a single-arm, multicenter, prospective study that included 200 subjects from 24 global sites. The primary end points were 12-month primary patency and major adverse events within 30 days. Secondary end points included lesion and procedure success, primary-assisted and secondary patency, major adverse events, stent migration, stent fracture, and quality of life changes. End point-related adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively.RESULTS:Venous obstruction cause was classified as acute deep vein thrombosis (16.5%, 33/200), post-thrombotic syndrome (47.5%, 95/200), or nonthrombotic iliac vein lesion (36.0%, 72/200). The common iliac and external iliac veins were stented in 96.0% (192/200), 80.5% (161/200) of subjects, respectively. Stent implant into the common femoral vein was required in 44.0% (88/200). Primary patency at 12 months was 88.0% (162/184). Four (2.0%) major adverse events occurred within 30 days. Twelve-month primary-assisted and secondary patency were 91.8% (169/184) and 92.9% (171/184), respectively. No stent fractures or migrations were reported. Mean target limb Villalta score decreased from 11.2±5.6 at baseline to 4.1±4.8 at 12 months, and the mean target limb revised Venous Clinical Severity Score decreased from 8.8±4.7 at baseline to 4.3±3.6 at 12 months. Clinically meaningful improvements in quality of life and venous functional assessment scores from baseline were demonstrated through 12 months in all measures.CONCLUSIONS:Symptomatic iliofemoral venous obstruction can be successfully treated with an Abre venous stent. Study outcomes demonstrated a high patency rate with a good safety profile. Patients demonstrated a significant reduction in clinical symptoms and improvement in quality of life that was maintained through 12-month follow-up. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03038438.

PURPOSE:To assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract. MATERIALS AND METHODS:Patients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed. RESULTS:A total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture. CONCLUSIONS:The results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.