PURPOSE:To test the hypothesis that procedural technique factors, particularly vessel preparation, would predict outcomes more strongly than anatomic complexity in patients with femoropopliteal in-stent restenosis (FP-ISR) treated with drug-coated balloons (DCBs). MATERIALS AND METHODS:From the PROMISING registry, 281 patients with FP-ISR underwent DCB treatment at 9 centers in China (2021-2023). The cohort had complex disease: 68.0% Tosaka Grade III total in-stent occlusions; mean total treated segment length, 26.0 cm (SD ± 11.4); 85.1% Trans-Atlantic Inter-Society Consensus C/D classification of the overall femoropopliteal segment; and 47.3% critical limb-threatening ischemia (CLTI). Primary endpoints were clinically driven target lesion revascularization (CD-TLR) and major adverse limb events (MALEs) at 12 months. Multivariable Cox regression analysis identified independent predictors. RESULTS:At 12 months, cumulative incidence rates were 12.6% for CD-TLR and 14.1% for MALE. Major amputation occurred in 0.7%, and amputation-free survival was 92.9%. Quality of life improved substantially (Vascular Quality of Life questionnaire score, 2.6 [SD ± 0.9] to 5.3 [SD ± 1.2]; P < .001). Predilation was the strongest independent predictor of favorable outcomes (CD-TLR, hazard ratio [HR], 0.28 [95% CI, 0.14-0.59; P < .001]; MALE, HR, 0.28 [95% CI, 0.14-0.58; P < .001]), whereas CLTI predicted worse outcomes (CD-TLR, HR, 2.44 [P = .008]; MALE, HR, 2.25 [P = .015]). Lesion length of ≥250 mm and Tosaka Grade III occlusion patterns were not significant predictors. CONCLUSIONS:In complex FP-ISR, adequate vessel preparation through predilation before DCB deployment was the strongest predictor of success, superseding anatomic complexity factors. These findings support routine predilation as a modifiable technical factor to optimize DCB outcomes in clinical practice.

Aims To evaluate whether the short-term clinical outcomes of drug-coated balloon (DCB)-based treatment differ between calcified and non-calcified femoropopliteal lesions and to determine whether calcification severity is independently associated with 365-day major adverse events (MAE). Methods This retrospective analysis of a prospective multicenter registry included 1,778 limb-procedure cases from 1,685 patients undergoing femoropopliteal DCB treatment. Calcification was classified as none, mild, moderate, or severe. The primary endpoint was 365-day MAE, comprising all-cause mortality, clinically driven target lesion revascularization (CD-TLR), and major amputation. Cox proportional hazards models with patient-clustered robust standard errors were used, and missing covariates were handled using multiple imputation. Results Calcification was absent in 358 cases, mild in 626, moderate in 528, and severe in 266. Increasing calcification severity was accompanied by greater patient risk, lesion complexity, and procedural intensity. Kaplan–Meier estimated 365-day MAE risks were 14.6%, 12.6%, 14.2%, and 20.0%, respectively (log-rank P = 0.029). After adjustment for patient- and lesion-level factors, hazard ratios relative to no calcification were 0.571 (95% CI 0.386–0.843) for mild, 0.711 (0.487–1.037) for moderate, and 0.791 (0.520–1.204) for severe calcification (global P = 0.038). No monotonic association was observed with increasing calcification grade (HR per grade 0.985, 95% CI 0.847–1.145; P for trend = 0.841). Estimated 365-day CD-TLR rates were 7.7%, 7.2%, 7.1%, and 10.7%, respectively (log-rank P = 0.368), and calcification grade was not independently associated with CD-TLR. Sensitivity analyses yielded consistent findings. Conclusions Greater calcification severity was associated with a higher-risk clinical profile, greater lesion complexity, and increased procedural intensity. After adjustment, calcification grade was not associated with a monotonic increase in 365-day MAE or CD-TLR. The comparable observed CD-TLR rates across calcification grades support the short-term clinical feasibility of DCB-based treatment for calcified femoropopliteal lesions.

OBJECTIVE:Femoropopliteal in stent re-stenosis (ISR) remains a significant challenge following endovascular peripheral artery occlusive disease procedures, with Tosaka III lesions representing the most complex form of complete occlusive re-stenosis. Limited prospective, observational study data have focused on endovascular treatment of femoropopliteal Tosaka III ISR. METHODS:The FP-RESTORE study was a prospective, observational study involving 13 Chinese hospitals from April 2021. It enrolled 322 consecutive patients (353 limbs) with femoropopliteal Tosaka III ISR undergoing endovascular intervention. Primary endpoints were clinically driven target lesion revascularisation (CD-TLR) and major adverse limb events (MALE) at 24 months. Competing risk regression analysis was performed to identify independent predictors of adverse outcomes. RESULTS:Of the enrolled patients, the mean age was 71.6 ± 9.1 years, with 54.67% presenting Rutherford grade > 3. Average occlusive lesion length was 22.0 ± 10.5 cm, with suspected thrombotic components presenting in 46.74% of lesions. Technical success rates were 96.88%. Ankle brachial index (ABI) improved statistically significantly from 0.33 ± 0.2 to 0.77 ± 0.22 post-operatively; ABI improved by more than 0.2 after the procedure and this was observed in 85.8% of patients. The follow up rate was 86.0% with a median follow up duration of 24.5 months. At 24 months, the CD-TLR rate was 21.4% (95% confidence interval [CI] 16.82 - 25.93%) and MALE rate was 27.2% (95% CI 22.26 - 32.21%). The all cause mortality rate was 14.3%. Independent predictors of CD-TLR and MALE included multiple previous procedures and popliteal artery (P2 and P3) involvement. CONCLUSION:Endovascular treatment for femoropopliteal Tosaka III ISR achieved acceptable immediate and 24 month outcomes. Multiple previous procedures and popliteal artery involvement were key predictors of adverse events, suggesting valuable guidance for risk stratification and treatment modification in this challenging patient population.

In a real-world setting, the impact of below-the-knee (BTK) runoff status on outcomes following drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions remains insufficiently studied, and robust evidence is still lacking. Between 2021 and 2024, a total of 1,574 patients undergoing drug-coated balloon (DCB) treatment for femoropopliteal arterial occlusive disease were retrospectively identified from 9 centers in China. Propensity score matching was applied to minimize baseline imbalances, resulting in 155 matched pairs for subsequent analysis. Outcome measures included 12-month amputation-free survival (AFS), freedom from clinically driven target lesion revascularization (CD-TLR), all-cause mortality, major adverse event rate, and amputation rate. Predictors of 12-month AFS were also analyzed. The mean age was 69.82 ± 9.16 years, and 78.06

Background The Wound, Ischemia, and Foot Infection (WIfI) classification system was proposed to improve risk stratification and prognostic prediction in chronic limb-threatening ischemia patients. Objectives The aim of this prospective, multicenter observational study was to evaluate the prognostic value of the WIfI classification in patients with infrapopliteal arterial occlusive disease undergoing endovascular therapy. Methods Patients from 10 Chinese centers were enrolled. The primary outcome was 12-month freedom from major adverse events (MAE), which was a composite of major amputation, all-cause death, and clinically driven target limb reintervention. Secondary outcomes included amputation-free survival and the composite components of the primary outcome. Results This study involved 944 patients (975 limbs). Cox regression analysis identified WIfI stage as an independent predictor of MAE (HR: 1.23; 95% CI: 1.06-1.43; P = 0.007). Additionally, WIfI stage was independently associated with combined major amputation or all-cause death (HR: 1.41; 95% CI: 1.18-1.69; P < 0.001) and with all-cause death alone (HR: 1.38; 95% CI: 1.12-1.70; P = 0.002). WIfI stage 4 carried a consistently higher risk for these 3 endpoints compared with stages 1 to 3. Although WIfI stage was independently linked to major amputation, pairwise comparisons did not show significant differences among stages. No independent association was observed between WIfI stage and clinically driven target lesion reintervention. Conclusions Although the WIfI classification system shows predictive ability for MAE, amputation-free survival, major amputation, and all-cause death, the prognostic differences are driven primarily by stage 4.

This study aimed to compare directional atherectomy (DA) and plain old balloon angioplasty (POBA) for vessel preparation before drug-coated balloon (DCB) therapy in moderately to severely calcified peripheral artery disease. This study is a sub-analysis of the Evolusion study. Inverse probability weighting was applied to balance the two groups. The primary endpoints were freedom from major adverse events (f-MAE), freedom from all-cause mortality (f-ACM), and major adverse limb events (MALE). Secondary endpoints included Rutherford classification improvement rate, bailout stent implantation rate, and bailout stent length. A total of 337 patients were included (254 in POBA group, 83 in DA group). POBA had higher bailout stent implantation rate (28.7

To compensate for the shortcomings of existing diagnostic methods in assessing the severity of peripheral arterial disease (PAD), this study proposed a novel non-invasive protocol for both diagnosing PAD and stratifying its severity. Surface electromyography (sEMG) and mechanomyography (MMG) signals from the gastrocnemius muscle were collected from subjects. The continuous wavelet transform was used to generate the Morlet scalogram of the processed sEMG. Subsequently, conventional feature extraction techniques were employed to procure time domain, frequency domain, and nonlinear features from the sEMG and MMG. A multimodal cascade fusion network was developed to integrate information from scalograms and multidomain features, enabling the detection and severity assessment of lower extremity PAD. The proposed method was subjected to a fourfold cross-validation experiment in 40 lower extremities. The mean sensitivity, specificity, accuracy, and F1 score were 92.36%, 96.23%, 95.00%, and 94.17%, respectively. The clinical evaluation of the method was performed on 18 lower extremities, with 17 lower extremities accurately classified. The achieved performance demonstrates the feasibility of assessing lower extremity PAD severity using gastrocnemius sEMG and MMG signals, providing a promising tool for routine PAD screening and aiding clinicians in informed decision-making.

Objectives:This study aims to evaluate the feasibility and advantages of the distal transradial approach (dTRA) for assessing blood supply in patients with lower limb ulcers. Methods:This study analyzed 66 patients with chronic lower limb ulcers who underwent lower limb angiography between December 2023 and October 2024. Among them, 44 patients were in the transfemoral access (TFA) group, and 22 patients were in the dTRA group. The success rate of the procedure, contrast dosage, time consumed for contrast, postoperative complications, patient Satisfaction Score and objective analysis of image quality were recorded and statistically analysed using SPSS 22.0. Results:The analysis revealed that there was no statistically significant difference in the procedural success rates between the two groups, with the TFA group achieving a 95% success rate compared to 86% in the dTRA group (P = 0.41). The amount of contrast agent used was significantly higher in the dTRA group than in the TFA group (70.79 ± 13.25 mL vs. 60.10 ± 16.98 mL, P = 0.02). However, there was no statistically significant difference in the complication rate (2.3% in the TFA group vs. 0% in the dTRA group, P = 1.00). Slightly more time-consuming imaging in the dTRA group (30 min vs. 25 min, P = 0.06). Patient satisfaction score in the dTRA group (4.16 ± 0.60) was better than the TFA group (3.12 ± 0.63, p = 0.00). The CNR (13.99 ± 7.92) in the dTRA group was lower than that in the TFA group (21.31 ± 10.57) (P = 0.009). Conclusions:The dTRA demonstrates diagnostic efficacy comparable to the TFA in evaluating lower limb blood supply in chronic lower limb ulcers patients, and significantly improves patient comfort with its minimally invasive access, early mobility, and low complication risk.

BACKGROUND:To evaluate drug-coated balloon (DCB) effectiveness for femoropopliteal disease in diabetic versus nondiabetic patients, using propensity score matching. METHODS:This multicenter registry analyzed 1,779 patients completing 1-year follow-up from 2,356 enrolled patients undergoing DCB treatment. Propensity matching, based on diabetes status, created 597 matched pairs balanced across 23 demographic and lesion characteristics. Primary endpoints included freedom from clinically driven target lesion revascularization and major adverse events at 12 months. Amputation-free survival and freedom from amputation outcomes were specifically analyzed in the chronic limb-threatening ischemia (CLTI) subgroup. RESULTS:Freedom from clinically driven target lesion revascularization rates were equivalent between diabetic and nondiabetic patients (93.63% vs. 93.84%, P = 0.912), confirming consistent DCB efficacy. Technical success exceeded 98% in both cohorts. Overall survival was 91.68% in diabetic patients versus 95.74% in nondiabetic patients (P = 0.009). In the CLTI subgroup (n = 431; diabetic patients n = 220, nondiabetic patients n = 211), amputation-free survival demonstrated significant risk stratification between diabetic and nondiabetic patients (81.39% vs. 90.19%, P = 0.022, hazard ratio 1.895, 95% confidence interval 1.117-3.214), while freedom from amputation remained excellent without significant difference between diabetic and nondiabetic patients (99.02% vs. 97.92%, P = 0.397, hazard ratio 0.488, 95% confidence interval 0.098-2.418). CONCLUSION:DCB angioplasty demonstrates comparable technical success and freedom from target lesion revascularization in diabetic and nondiabetic patients. However, diabetic patients exhibited significantly lower overall survival and, in the CLTI subgroup, reduced amputation-free survival, despite similar freedom from amputation rates.

OBJECTIVE:The objective of this study was to investigate the relationship between preoperative below-the-knee (BTK) runoff and major adverse limb event (MALE)-free survival, as well as clinically-driven target lesion revascularization (CD-TLR) and all-cause mortality, in patients with femoropopliteal occlusive disease (FPOD) treated with drug-coated balloons (DCB). METHODS:A large-scale, multicenter, prospective study was initiated in January 2021. Endpoint outcomes were obtained prior to December 31, 2024. The exposure of interest was BTK runoff, with the primary endpoint being MALE-free survival, and secondary endpoints being CD-TLR and all-cause mortality. Multivariate Cox regression was employed to control for confounding variables, and stratified analyses were conducted. RESULTS:A total of 1757 participants (36.1% male) with a mean (SD) age of 71.2 (9.5) years were enrolled in the study. The median follow-up duration was 1.5 years. In the fully adjusted model, 1 runoff, 2 runoff and 3 runoff were associated with significantly lower incidences of MALE or death compared with 0 runoff (1 runoff: hazard ratio [HR]=0.75, 95% confidence interval [CI]: 0.56, 1.00, p=0.054; 2 runoff: HR = 0.63, 95% CI: 0.46, 0.87, p=0.006; 3 runoff: HR=0.49, 95% CI: 0.34, 0.72, p<0.001). In addition, 3 runoff demonstrated a lower incidence of CD-TLR (HR=0.56, 95% CI: 0.35, 0.90, p=0.017) and all-cause mortality (HR=0.47, 95% CI: 0.25, 0.89, p=0.021) compared with 0 runoff. There was a significant trend toward reduction in the incidence of all 3 endpoints with increasing numbers of BTK runoff vessels (p for trend <0.05). The relationship between BTK runoff and the endpoints was consistent across all subgroups, with no significant interaction observed. CONCLUSIONS:In patients with FPOD treated with DCB, a higher number of BTK runoff vessels was significantly associated with fewer MALE or death, fewer CD-TLR, and fewer deaths. This association was independent of traditional cardiovascular risk factors and represents an important stratification factor for patient outcomes (The PROMISING Study, NCT04826705).Clinical ImpactThis large, prospective multicenter study demonstrates that preoperative below-the-knee (BTK) runoff remains a strong and independent prognostic factor in patients undergoing femoropopliteal drug-coated balloon (DCB) therapy. Despite the antiproliferative benefits of DCBs, distal hemodynamics continue to influence procedural durability and long-term limb outcomes. Our findings show a graded reduction in MALE, CD-TLR, and mortality with increasing runoff vessels, independent of lesion complexity, stent implantation, and concomitant outflow intervention. These results reinforce the importance of systematic preprocedural runoff assessment and support incorporating BTK runoff into risk stratification, patient counseling, and surveillance planning in contemporary endovascular practice.

This study aims to evaluate the 12-month clinical outcomes of drug-coated balloon (DCB) treatment for infrapopliteal chronic limb-threatening ischemia (CLTI) in a real-world setting, and to provide evidence to inform clinical decision-making. Based on the PRIME-WIFI multicenter prospective registry, 538 patients (553 limbs) from 10 centers were consecutively enrolled between December 2020 and June 2023. All patients underwent infrapopliteal DCB angioplasty and were included in the 12-month outcome analysis. The primary endpoint was the freedom from major adverse events (MAE), including major amputation, all-cause mortality, and clinically driven target limb reintervention (CD-TLR). Secondary endpoints included amputation-free survival (AFS), sustained clinical improvement, and quality of life. The Kaplan–Meier method was used to estimate event rates, and Cox regression was applied to identify independent predictors of 12-month MAE. The 12-month MAE-free rate was 75.5

PURPOSE:To compare the 2-year outcomes of drug-eluting stents (DES) versus drug-coated balloons (DCB) plus bare-metal stents (BMS) in patients with femoropopliteal artery disease. MATERIALS AND METHODS:Data were analyzed from The Impact of Tibial Runoff on Clinical Outcome of Endovascular Therapy in Femoropopliteal Lesions (TALENT) study, a multicenter, prospective study. Inverse probability of treatment weighting was applied to balance baseline characteristics. The primary outcomes were freedom of all-cause mortality, freedom of major adverse events, clinically driven target lesion revascularization (CD-TLR), and major adverse limb events (MALEs), and the secondary outcomes were the improvement in Rutherford classification and changes in quality of life assessed by the 25-item Vascular Quality of Life questionnaire. RESULTS:A total of 429 patients were included (81 in DES group; 348 in DCB plus BMS group). During a median (Q1-Q3) follow-up of 20.2 months (11.6-27.1 months), no significant differences were observed between the 2 groups in 2-year freedom of all-cause mortality (91.4% vs 85.1%; P = .096), freedom of major adverse events (79.6% vs 73.9%; P = .330), CD-TLR (9.6% vs 12.6%; P = .737), and MALEs (10.1% vs 12.3%; P = .612). Both treatment modalities significantly improved in VascuQol score and Rutherford classification, with improvement rates of 76.1% and 71.3% at 24 months, respectively. An interaction effect (P = .014 and .005, respectively) was observed for patients with intermittent claudication (R2-R3), suggesting that DES may be associated with lower risks of CD-TLR and MALEs. CONCLUSIONS:Over the 2-year follow-up, DES and DCB plus BMS demonstrated favorable and comparable overall effectiveness in real-world patients with complex femoropopliteal lesions.

This retrospective multicenter cohort study from the PROMISING registry compared directional atherectomy (DA) and plain old balloon angioplasty (POBA) as vessel preparation before drug-coated balloon (DCB) therapy for femoropopliteal occlusive disease. After propensity score matching, 147 DA-treated and 480 POBA-treated patients were analyzed with well-balanced baseline characteristics. DA markedly reduced the need for stent implantation (8.8% vs. 20.4%) and shortened total stent length, while allowing subsequent use of larger-diameter DCBs. Major peri-operative complications were rare in both groups, but minor complications were more frequent after DA. Postoperative ankle-brachial index and Rutherford classification improved significantly in both groups, without intergroup differences. During 24-month follow-up, Kaplan-Meier analysis showed no significant differences between DA and POBA in all-cause mortality, clinically driven target lesion revascularization, amputation-free survival, or major adverse limb events. Subgroup analyses revealed that patients with chronic total occlusion (CTO) derived greater benefit from DA, with a significant interaction (P for interaction = 0.002), whereas outcomes were consistent across other subgroups. Overall, DA before DCB therapy effectively reduces stent use and enhances vessel preparation without compromising long-term efficacy or safety, supporting its selective application in complex femoropopliteal lesions, particularly those with CTO.

OBJECTIVE:Real-world evidence comparing dual-pathway inhibition (DPI) with dual antiplatelet therapy (DAPT) after endovascular revascularization for acute or nonacute limb ischemia is limited. This study aims to compare the 24-month effectiveness and safety outcomes of DPI versus DAPT in this setting. METHODS:This prospective, multicenter observational study from the RESOLVE registry used propensity score matching (PSM) to analyze patients receiving DPI or DAPT after endovascular revascularization. The primary endpoint was 24-month major adverse events (MAE) including recurrent acute limb ischemia, major amputation, myocardial infarction, ischemic stroke, or cardiovascular death. Secondary endpoints included major adverse limb events (MALE), major adverse cardiovascular events (MACE), and all-cause death. RESULTS:After PSM, 109 matched pairs were analyzed. The DPI group had significantly lower 24-month MAE incidence than the DAPT group (11.47% vs 28.45%; HR = 2.83; P < .01), as well as lower MALE (16.83% vs 28.40%; HR = 1.83; P = .04) and all-cause death (2.94% vs 11.65%; HR = 4.28; P = .02). MACE showed a trend toward lower incidence with DPI (2.00% vs 7.77%; HR = 4.22; P = .07). No major bleeding events were observed in either group. Modified SVS run-off score >10 and chronic limb-threatening ischemia predicted greater DPI benefit (P for interaction=.020 and .031). CONCLUSIONS:In this PSM analysis, DPI was associated with significantly lower 24-month rates of MAE, MALE, and all-cause death compared with DAPT. No major bleeding events were observed in either group. These findings suggest a potentially favorable efficacy profile for DPI but warrant confirmation in further randomized controlled trials.

ObjectivesThe aim of this study was to evaluate the one-year results of the Eluvia drug-eluting vascular stent (Boston Scientific, Marlborough, MA, USA) for the treatment of femoropopliteal occlusive disease (FPOD).MethodsFrom January 2021 to November 2023, this multicenter study prospectively enrolled patients with peripheral artery disease involving the femoropopliteal artery. The primary outcome measures were the rate of freedom from clinically driven target limb revascularization (f-CD-TLR), rate of freedom from major adverse events (f-MAE), rate of freedom from symptom recurrence (f-SR) and rate of freedom from all-cause death (f-ACD). The secondary outcome measures were the Rutherford grade and Vascular Quality of Life (VascuQoL) scale scores.ResultsIn total, 159 patients were enrolled in this study. The mean follow-up time was 370 days, and the follow-up rate was 83.0%. The patients' mean age was 72 years, and 82.4% were male. A total of 159 patients received 199 stent deployments. The mean lesion length was 194.4 ± 118.9 mm, and 76.7% had total occlusions. The technical success rate for endovascular treatment was 100%, and five complications occurred during the perioperative period. At one, three, six, and 12 months, the f-CD-TLR rate was 99.3%, 97.9%, 96.4%, and 92.8%, respectively; the f-MAE rate was 98.0%, 96.7%, 93.1%, and 91.3%, respectively; the f-SR rate was 94.6%, 85.5%, 80.3%, and 73.4%, respectively; and the f-ACD rate was 98.0%, 98.0%, 95.9% and 94.1%, respectively. There was a substantial increase in the Rutherford grade and average VascuQoL scores at the one-, three-, six-, and 12-month follow-ups (p < .001).ConclusionsThe Eluvia stent had a favorable effect on FPOD throughout 12 months of follow-up. Further studies with larger sample sizes and longer-term follow-up are required to confirm the real-world performance of the Eluvia stent.

Specialty balloons are a novel category of vessel preparation devices. This study compared their effectiveness and safety with plain old balloon angioplasty (POBA) in a real-world setting. A total of 1,574 patients who underwent drug-coated balloon (DCB) therapy for femoropopliteal occlusive disease at ten Chinese centers (2021-2023) were analyzed. Propensity score matching generated 434 balanced pairs. Compared with POBA, specialty balloons were associated with a lower stent implantation rate (19% vs 28%; p = 0.003), shorter median stent length (15 cm vs 19 cm; p = 0.017), and use of larger-diameter DCB (4.9 ± 0.5 mm vs 4.8 ± 0.6 mm; p < 0.001). Perioperative complications, ankle-brachial index, hospital stay, and 1-year outcomes-including clinically driven target lesion revascularization, major amputation, mortality, and composite endpoints-did not differ between groups. In the overall cohort, 26% required stenting. Independent predictors of stent implantation were chronic total occlusion, smoking, moderate-to-severe calcification, and greater lesion length, while specialty balloon use was protective. In conclusion, compared with POBA, specialty balloon demonstrated superior vessel preparation outcomes, manifesting as significantly reduced stent implantation requirements, shorter average stent length, and enabling the use of larger-diameter DCB.

Introduction Acute and subacute thrombotic occlusions of the lower extremities are common subtypes of peripheral artery disease frequently encountered in clinical practice. These occlusions typically involve the obstruction of a native artery or bypass graft, primarily caused by thrombosis or embolism. Endovascular therapy has increasingly become the preferred first-line treatment for patients with acute or subacute thromboembolic occlusions in the lower extremities. Thrombectomy, the removal of the thrombus, represents a critical initial step in endovascular management. A range of thrombectomy devices is currently available to treat such occlusions. However, the efficacy and safety of endovascular treatments remain uncertain, with real-world evidence on thrombectomy devices showing inconsistency across studies and clinical settings. This study aims to rigorously assess the safety and efficacy outcomes of endovascular treatment strategies for acute or subacute thromboembolic occlusions in the lower extremities.Methods and analysis This prospective, cohort, multicentre, real-world observational study will enrol 400 patients diagnosed with acute or subacute thromboembolic occlusions of the lower extremity, treated with endovascular therapy across nine centres from 1 January 2021 to 31 December 2025. Participants will be followed for 12 months, with relevant demographic and clinical data collected. Follow-up assessments will occur at 1, 3, 6 and 12 months postintervention. The primary effectiveness endpoint is amputation-free survival. Secondary outcomes include adverse events at 1 month postintervention, technical success rate, clinical-driven target lesion reintervention rate, primary patency of the lesions and health economics considerations.Ethics and dissemination The RESOLVE clinical study is registered on ClinicalTrials.gov (http://clinicaltrials.gov/). Ethical approval was granted by the Institutional Review Board and the Human Research Ethics Committee of Hangzhou First People’s Hospital (approval number: 2021No.15-1). Informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through publication in a reputable, peer-reviewed journal, contributing valuable insights to guide future clinical practice in this field.Trial registration number NCT04861506.

To evaluate the efficacy and safety of the S.M.A.R.T. Flex stents for treating femoropopliteal (FP) occlusive lesions, including complex Trans-Atlantic Inter-Society Consensus (TASC) II C/D and severely calcified lesions. This retrospective study utilized the TALENT registry database (a prospective study), enrolling patients who underwent S.M.A.R.T. Flex implantation from January 2021 to July 2022. The primary effectiveness endpoint was the rate of freedom from clinically driven target lesion revascularization (CD-TLR) at 18 months, and the primary safety endpoint was the 18-month rate of freedom from major adverse events (all-cause death, above-the-ankle target limb amputation, or CD-TLR). A total of 122 patients with 124 limbs were included, with an average follow-up of 617 days. The average lesion length was 24.9 ± 20.4 cm, and 73.8 and 54.1

Background Diabetes peripheral neuropathy (DPN), one of the most common complications in people with diabetes, can seriously undermine their quality of life. Early detection and treatment of DPN is of great significance to the diabetes population. Nerve conduction studies, the gold standard for diagnosing DPN, causes substantial discomfort for people and requires specialized personnel and expensive equipment, making it challenging to implement as a mass screening tool for DPN. Methods Here, a novel, non-invasive and convenient screening method for DPN is proposed. In the proposed method, surface electromyography and mechanomyography data are acquired in a non-invasive and painless manner from people’ dorsalis pedis muscles. The acquired data are then processed by means of downsampling, motion data extraction, and subsequently converted into images, which are utilized for diagnosing DPN or non-DPN by a convolutional neural network. Findings The proposed method is developed based on actual data from 167 people with diabetes. After 4-fold cross validation of the method, the mean accuracy, sensitivity and specificity are evaluated to be 96.15 %, 91.39 % and 98.78 % with variances of 0.003 %, 0.017 % and 0.00014 %, respectively. Furthermore, the method is preliminary tested on 21 people with diabetes, resulting in accuracy, sensitivity and specificity of 95.48 %, 90.91 % and 98.88 %, respectively. Notably, the screening process for a single diabetic using this method can be completed in under 10 min. The results above demonstrate the efficacy of the method in diagnosing DPN. Interpretation The proposed method has the considerable potential for noninvasive and convenient screening of DPN without requiring professionals or expensive equipment.

OBJECTIVE:This study evaluated two year clinical outcomes of endovascular treatment for femoropopliteal artery disease with moderate to severe calcification in a Chinese cohort and identified predictors of prognosis. METHODS:This was a prospective, observational, multicentre cohort study of patients with moderate to severe calcified femoropopliteal peripheral artery disease prospectively enrolled in the Evolusion study from December 2020 to October 2023 (ClinicalTrials.gov ID: NCT04716361). Outcomes included clinically driven target limb revascularisation (CD-TLR), major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), all cause mortality (ACM), Rutherford classification, and Vascular Quality of Life (VascuQoL) scores. RESULTS:A total of 944 patients (mean age 74.7 years; 67.7% male) were enrolled, with 51.9% diagnosed with chronic limb threatening ischaemia (CLTI) and a 2 year follow up rate of 80.9%. Cumulative CD-TLR rates at 1, 3, 6, 12, 18, and 24 months were 0.54%, 1.30%, 2.54%, 5.03%, 7.43%, and 9.27%, respectively. MALE rates were 0.97%, 1.84%, 3.08%, 6.27%, 9.39%, and 11.41%, and MACE rates were 0.76%, 1.63%, 3.23%, 4.58%, 7.51%, and 8.24%, respectively. Freedom from ACM was 98.60%, 97.39%, 95.06%, 90.09%, 84.35%, and 82.29%. Statistically significant improvements in Rutherford classification and VascuQoL scores were observed throughout follow up (p < .001). Previous target limb intervention (hazard ratio [HR] 3.81; p = .022) and severe calcification (HR 1.58; p = .029) independently predicted MALEs, whereas chronic kidney disease (HR 2.73; p < .001) and CLTI (HR 2.72; p < .001) were associated with a higher ACM. Post-operative lipid lowering therapy (HR 0.58; p = .003) was a potential independent protective factor against ACM events. CONCLUSION:This study reported two year outcomes of endovascular treatment for moderately to severely calcified femoropopliteal artery disease in a Chinese population and identified potential independent risk and protective factors to aid risk stratification and therapeutic decision making.