The VIVA Foundation, a not-for-profit organization dedicated to advancing vascular medicine through education and research, announced results from six Late-Breaking Clinical Trials presented this morning at VIVA 2026, held at Bellagio Las Vegas.
For 24 years, VIVA (Vascular InterVentional Advances) has set the benchmark for premier education and clinical excellence in peripheral vascular disease. Known for delivering the most up-to-date, practice-changing data, VIVA brings together the latest science, technological innovation, and international expertise.
Comparison of a Sirolimus-Eluting Balloon vs Balloon Angioplasty for the Treatment of Femoropopliteal Artery Lesions
Presented by Jay Mathews, MD, MS
SELUTION4SFA is a prospective, multicenter, single-blinded, 2:1 randomized, controlled, clinical trial to evaluate superior efficacy and non-inferior safety of the SELUTION SLR™ (Sustained Limus Release) Drug-Eluting Balloon (DEB) compared to percutaneous transluminal angioplasty (PTA) in the treatment of patients with symptomatic peripheral artery disease (PAD) in the superficial femoral artery and proximal popliteal artery.
This study enrolled 300 subjects at 34 clinical sites in the United States (US), Europe (EU) and Asia. Subjects were randomized 2:1 to treatment with SELUTION SLR™ DEB or with commercially available PTA (POBA). The primary efficacy endpoint to test for superiority was primary patency of the target lesion at 12 months. The primary safety endpoint for non-inferiority was a composite of freedom from perioperative death at 30 days, and 12-month freedom from target limb amputation and CD-TLR. Other 12-month endpoints included Kaplan-Meier (KM) estimates of primary patency and freedom from CD-TLR.
Of the 300 patients enrolled, 205 were treated with SELUTION SLR™ DEB and 95 with PTA. Mean age was 70.8±9.4 years for DEB and 70.5 ± 9.1 years for POBA. 41.5% of DEB patients were diabetic compared to 40.0% of POBA patients (p=0.90). Lesion lengths in DEB and POBA were 9.3±5.8cm and 7.2±5.0cm (p=0.002), respectively.[HC1] 50.5% of DEB lesions and 47.8% of POBA lesions were severely calcified (p=0.82).
SELUTION SLR™ DEB met superiority for efficacy compared to POBA (78.6% vs. 65.2%, p=0.019) and met non-inferiority for safety (92.8% vs. 84.2%, p<0.0001). Primary patency by KM estimate was 90.3% in DEB vs. 79.4% in POBA, and freedom from CD-TLR was 94.6% in DEB vs. 85.3% in POBA.
The SELUTION4SFA trial is the first investigational device exemption clinical trial and the first randomized clinical trial in the US for a sirolimus DEB compared to plain balloon angioplasty for the treatment of PAD.
Sirolimus-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease
Presented by Stefano Barco, MD, PhD
Peripheral artery disease involving the femoropopliteal segment commonly causes exertional symptoms, and restenosis after endovascular treatment frequently leads to repeat intervention. Although drug-coated balloons are used to improve durability, randomized evidence comparing sirolimus-coated versus standard uncoated balloons in this population has been limited.
This secondary analysis of the multicenter, randomized, blinded-endpoint SirPAD trial (ClinicalTrials.gov: NCT04238546) evaluated patients with femoropopliteal target lesions and no tissue loss. Patients had been randomized 1:1 to angioplasty with a sirolimus-coated balloon or a standard uncoated balloon. The main analysis included 597 patients; median age was 71 years, 34.7% were women, median target-lesion length was 150 mm, and 53.8% of lesions were total occlusions. Outcomes at 1 year included target-lesion revascularization (TLR), major adverse limb events, amputation or TLR, and all-cause mortality.
At 1 year, TLR occurred in 17.0% of patients treated with sirolimus-coated balloons versus 27.1% with uncoated balloons (absolute risk difference [ARD], –10.1%; 95% CI, –16.6 to –3.4; HR, 0.58; 95% CI, 0.40–0.82). Major adverse limb events occurred in 4.1% versus 8.9% (ARD, –4.8%; HR, 0.44; 95% CI, 0.22–0.88), and the composite of any unplanned amputation or TLR occurred in 17.7% versus 27.1% (ARD, –9.4%; HR, 0.60; 95% CI, 0.42–0.85). Target-limb revascularization occurred in 19.4% versus 28.4% (HR, 0.63; 95% CI, 0.45–0.89). Clinical improvement by at least one Rutherford category occurred in 76.2% versus 70.0% (RR, 1.09; 95% CI, 0.99–1.20). All-cause mortality was similar (3.7% vs. 5.3%; HR, 0.70; 95% CI, 0.32–1.51). Findings were consistent in the more restrictive lower-disease-burden subgroup.
These results suggest that sirolimus-coated balloon angioplasty reduces repeat revascularization and improves clinical outcomes compared with uncoated balloon angioplasty in patients with femoropopliteal artery disease without tissue loss.
24-Month Data From the SUCCESS PTA Study: Performance of a Novel Sirolimus-Eluting Balloon in Real-World Peripheral Artery Disease Patients
Presented by Thomas Zeller, MD
The objective of the SUCCESS PTA study is to evaluate the safety and efficacy of the novel SELUTION SLR™ 018 sirolimus-eluting balloon in the treatment of real-world patients with peripheral arterial disease (PAD). This is a report of the entire cohort at 24-month follow-up.
SUCCESS PTA is a real-world, prospective, multi-center, single-arm post-market study of the SELUTION SLR™ for treatment of de novo/restenotic lesions in SFA, popliteal, tibial and pedal arteries. 720 patients were enrolled at 27 sites in Europe, Asia, and South America from February 2021 to October 2023. The primary endpoint of the study is freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Major secondary endpoints are severe limb ischemia leading to an intervention or major vascular amputation and death. Follow-ups after 12 months are planned yearly for up to 5 years.
Baseline demographics included 468 males (65%), and the mean age was 70.7 years. Significant co-morbidities included diabetes mellitus (273; 37.9%), renal insufficiency (121; 16.8%) and 186 (25.8%) were CLTI patients (Rutherford 4, 5, or 6). The mean lesion length was 128.4 mm and the reference vessel diameter was 5.2 mm. 42.1% of the lesions were totally occluded and 36.3% had calcification grade 3 and 4. 24-month outcomes showed clinical improvement associated with 86.1% freedom from CD-TLR overall and 83.0% for the CLTI subgroup.
SUCCESS PTA is one of the largest studies of a sirolimus drug-eluting balloon (DEB), enrolling more than 700 real-world patients treated for PAD. The 24-month follow-up data highlight consistency and durability of SELUTION SLR™ DEB’s safety and efficacy in treating real-world PAD patients. The findings of this analysis will contribute valuable evidence toward the expanding role of sirolimus-based DEBs in the endovascular management of peripheral arterial disease.
Montelukast Reduces Risk of Major Adverse Limb Events After Endovascular Treatment: First Results of the CADET-PAD study
Presented by Mikołaj Maga, MD, PhD
Peripheral arterial disease (PAD) treatment includes risk factor reduction, optimal pharmacological treatment, walking training, and open-surgical or endovascular revascularization. Despite new techniques and the constant development of endovascular tools, restenosis, leading to artery occlusion, remains a frequent issue. Given the observed correlation between increased leukotriene synthesis and unfavorable endovascular treatment outcomes, the aim of this study was to assess the impact of leukotriene antagonist (montelukast) use on the rate of major adverse limb events (MALE).
In this prospective, double-blinded clinical trial, patients with PAD (Rutherford 3 and 4) undergoing endovascular treatment were enrolled. They were randomized 1:1 to two groups: a study group receiving 10 mg of montelukast daily for 12 months and a control group receiving a placebo. Both groups were additionally provided with standard optimal post-angioplasty pharmacological treatment. The follow-up visits, including physical examination, quality of life assessment, Doppler ultrasound, ABI/TBI, urine and blood sampling, were performed at 1, 3, 6, 9 and 12 months after revascularization.
200 patients (mean age 64.7 years, 78.9% Rutherford 3, 35.5% CAD, 39.0% DM t II, 88.0% hypertension) were enrolled. In the 12-month observation, there was a significant reduction of MALE in the montelukast group (n=16 vs n=34, p < 0.001). The primary patency rate after 12 months was higher in the montelukast group (84.0% vs 66.0%, p< 0.001), accompanied by greater improvements in quality of life (VascuQol, p< 0.01) and endothelial parameters (FMD, SI, p< 0.05). The 12-month MACE rate (n=2 vs n=6, p < 0.001), including death rate (n=1 vs n=3, p < 0.01), was significantly lower in the montelukast group.
Montelukast has been proven to be clinically effective in reducing the rate of MACE, including restenosis or reocclusion, in patients undergoing EVT. The results suggest that inhibition of the leukotriene-mediated inflammatory pathway may play a significant role in the treatment of atherosclerosis and should be considered, especially in patients with recurrent restenosis of unknown cause after revascularization.
Real-World 6-Month Outcomes of the Esprit BTK Drug-Eluting Resorbable Scaffold in CLTI: Results From the Post-Approval Study
Presented by Brian DeRubertis, MD
The Esprit BTK Post-Approval Study (PAS) evaluates the real-world safety and effectiveness of the Esprit™ BTK drug-eluting resorbable scaffold (DRS) in patients with infrapopliteal disease and chronic limb-threatening ischemia (CLTI). The Esprit BTK DRS combines temporary vessel scaffolding with local delivery of everolimus and resorbs over time, leaving no permanent implant. While the LIFE-BTK randomized trial demonstrated superior effectiveness compared with angioplasty, real-world evidence in broader and more clinically complex populations has been limited.
Esprit BTK PAS is a prospective, single-arm, multicenter, observational post-approval study conducted across 50 sites globally. The primary effectiveness endpoint is freedom from clinically driven target lesion revascularization (CD-TLR), while the primary safety endpoint is the composite of major adverse limb events (MALE) and perioperative death (POD).
Enrollment was completed at 210 patients; this analysis reports 6-month outcomes for the first 200 enrolled subjects. The cohort represented a highly complex CLTI population, with 64% presenting with an index wound, 63% classified as Rutherford-Becker class 5 or 6, 77% having diabetes, and 13% having end-stage renal disease (ESRD). Lesions were similarly challenging, with a mean length of 69 mm, 59% exhibiting moderate-to-severe calcification, 23% classified as TASC D, and 43% presenting as total occlusions.
At 6 months, freedom from CD-TLR was 93.8%, while the MALE + POD rate was 5.5%. MALE occurred in 3.9% of patients, POD in 1.7%, and no major reinterventions were reported. Amputation-free survival was 88%, and complete wound healing was observed in 52.9% of evaluable patients. Mortality and major amputations were concentrated among patients with advanced disease, particularly those with ESRD. Despite substantial clinical and lesion complexity, the Esprit BTK DRS demonstrated favorable 6-month safety and effectiveness outcomes, supporting its use in routine clinical practice and providing the first large-scale real-world evidence for a resorbable scaffold platform in patients with CLTI.
Clinical Outcomes of the MOTIV Sirolimus-Eluting Resorbable Scaffold in Rutherford Category 4 Versus Rutherford Category 5 Chronic Limb-Threatening Ischemia: Subgroup Analysis From the MOTIV Pivotal Trial
Presented by Ehrin Armstrong, MD
The MOTIV BTK Trial is a prospective, multicenter, single-blind, randomized controlled study designed to assess the safety and efficacy of the MOTIV sirolimus-eluting resorbable scaffold for treating de novo infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Because outcomes are known to differ by clinical severity, subgroup analyses were conducted in Rutherford Category (RC) 4 patients (ischemic rest pain) and RC5 patients (distal tissue loss), a higher-risk group with historically greater rates of endovascular failure.
A total of 292 patients were enrolled and randomized 1:1 to treatment with the MOTIV scaffold or standard percutaneous transluminal angioplasty (PTA). Of these, 202 patients (69.2%) were RC5 and 90 (30.8%) were RC4. Clinical and imaging follow-up was performed through 12 months. The primary efficacy endpoint was freedom from a composite of above-ankle amputation, target lesion occlusion, clinically driven target lesion revascularization, and binary restenosis.
The presentation will compare baseline lesion characteristics and key safety and efficacy outcomes between RC4 and RC5 subgroups. Despite the more advanced disease burden in RC5 patients, the MOTIV sirolimus-eluting resorbable scaffold showed consistent effectiveness and a favorable safety profile across both severity groups. Overall, the findings suggest scaffold-based sirolimus delivery may provide clinical benefit across the spectrum of CLTI, including patients presenting with advanced tissue loss, supporting the use of the MOTIV scaffold in high-risk infrapopliteal interventions.
About the VIVA Foundation
The VIVA Foundation is a nonprofit organization dedicated to advancing vascular medicine through education and research. Bringing together experts in vascular medicine, interventional cardiology, interventional radiology, and vascular surgery, the Foundation provides multidisciplinary education designed to improve patient care and advance innovative therapies for vascular disease worldwide.
To learn more about the VIVA Foundation, visit https://viva-foundation.org/.
Media personnel should contact press@viva-foundation.org with questions.
[HC1]If we have the room, I'd add in the severe calcification here.
