World’s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon - Six-Month Results From the PRESTIGE Study

Sep 14, 2026

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The study evaluates the 6-month efficacy and safety of the Selution SLR sirolimus-eluting balloon in patients with chronic limb-threatening ischemia (CLTI) and TASC II C/D tibial occlusive lesions, addressing the limited evidence for sirolimus-coated devices in this high-risk setting. PRESTIGE is a pilot, prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Primary outcomes include adverse event-free survival at 1 month, technical success, primary tibial patency at 6 months, limb salvage, target lesion revascularization, and amputation-free survival.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages12

Reading Time30 min

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Abstract

Introduction

Original Article World’s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study Journal of Endovascular Therapy 1–12 © The Author(s) 2021 Article reuse guidelines: [sagepub.com/journals-permissions](sagepub.com/journals-permissions)[ ](sagepub.com/journals-permissions)[DOI: 10.1177/15266028211007457](DOI: 10.1177/15266028211007457)[ ](DOI: 10.1177/15266028211007457)[www.jevt.org](www.jevt.org) Tjun Yip Tang, MA (Cantab), MB BChir, MD, FRCS, FAMS 1,2, Charyl Yap, BSc (Hons) 1, Shereen Xue Yun Soon, BSc (Hons) 1, Sze Ling Chan, BSc (Pharm)(Hons), PhD3, QingWei Shaun Lee, MBBS, MMed, FRCS 1, Hao Yun Yap, MBBS, MMed, FRCS 1, Hsien Ts’ung Luke Tay, MBBS, MSc, MMed, FRCS 1, and Tze Tec Chong, MBBS, FACS, RPVI 1 Abstract Purpose: The performance of sirolimus-coated devices has not been studied in patients with chronic limb-threatening ischemia patients. PRESTIGE aims to investigate the 6-month efficacy and safety profile of the Selution Sustained Limus Release (SLR) sirolimus-eluting balloon for treatment of TASC II C and D tibial occlusive lesions in patients with CLTI. Materials and Methods: PRESTIGE is a pilot prospective, nonrandomized, single-arm, multi-investigator, single-center clinical study. Endpoints were adverse event-free survival at 1 month, technical success rate, primary tibial patency at 6 months, limb salvage success, target lesion revascularization (TLR), and amputation free survival (AFS). Results: A total of 25 patients were included. There were 17 (68.0%) males; mean age, 63.7 ±9.73 years. CLTI severity was based on the Rutherford scale (R5=25/25; 100.0%). Significant comorbidities included diabetes mellitus (n=22; 88.0%) and end-stage renal failure (n=11; 44.0%). A total of 33 atherosclerotic lesions were treated (TASC II D=15 (45.5%)). Mean lesion length treated was 191 ± 111 mm. Technical success was 100%. Primary tibial patency at 6 months was 22/27 (81.5%) and freedom from clinically driven TLR was 25/30 (83.3%). AFS was 21/25 (84.0%; 3 deaths and 1 major lower extremity amputation). Mean Rutherford score improved from 5.00 at baseline to 1.14 ±2.10 (p <0.05) at 6 months. There was a wound healing rate of 13/22 (59.1%) and 17/21 (81.0%) at 3 and 6 months respectively. Conclusions: Selution SLR drug-eluting balloon is a safe and efficacious modality in treating complex tibial arterial occlusive lesions in what is an otherwise frail cohort of CLTI patients, with a high prevalence of diabetes and end-stage renal failure. Technical and clinical success rates are high and 6-month target lesion patency and AFS are more than satisfactory. Keywords sirolimus, drug-coated balloon, Selution SLR, percutaneous angioplasty, chronic limb threatening ischemia, limb salvage, wound healing, outcome Introduction Peripheral arterial disease (PAD) is the atherosclerotic occlusive disease of the lower extremity arteries and afflicts hundreds of millions of individuals worldwide.1 Its most severe manifestation is chronic limb-threatening ischemia (CLTI), which is defined by the presence ofischemic rest pain, lower limb ulceration, or gangrene for more than 2 weeks’duration.2 Patients with CLTI usually present with multilevel infra-inguinal PAD and tibial arterial occlusions.2 An endovascular-first revascularization policy using percutaneous angioplasty (PTA) is currently preferred to reestablish straight-line blood flow to the foot.3 Despite an excellent technical success rate ( >90%), tibial 1 Department of Vascular Surgery, Singapore General Hospital, Singapore 2Duke-NUS Graduate Medical School, Singapore 3Health Services Research Center, SingHealth, Singapore Corresponding Author: Tjun Yip Tang, Department of Vascular Surgery, Singapore General Hospital, Level 5, Academia, 20 College Road, 169856, Singapore. Email: [tang.tjun.yip@singhealth.com.sg](tang.tjun.yip@singhealth.com.sg) a

FAQs

What question does the PRESTIGE study address about sirolimus-coated devices?

It investigates the 6-month efficacy and safety of the Selution SLR sirolimus-eluting balloon for treating TASC II C and D tibial occlusive lesions in CLTI patients.

How was the PRESTIGE study designed and what endpoints were used?

It is a pilot prospective, nonrandomized, single-arm clinical study. Endpoints include adverse event-free survival at 1 month, technical success, primary tibial patency at 6 months, limb salvage, target lesion revascularization, and amputation-free survival.

What were the key 6-month efficacy and safety results reported?

Technical success was 100%. Primary tibial patency at 6 months was 81.5% (22/27), freedom from clinically driven TLR was 83.3% (25/30), and amputation-free survival was 84.0% (21/25), with reported deaths and one major lower extremity amputation.

Sep 14, 2026

Uploaded by Jiven