Trial reportJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2021
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.
Trial report in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 30 citations in OpenAlex.
- Sirolimus-eluting balloon for the treatment of peripheral artery disease: SUCCESS PTA real-world single-arm study.CVIR endovascular · 2026Article
- Advances in Drug-Eluting Angioplasty Balloon Coatings, Clinical Implications and Future Directions: A Mini Review.Current vascular pharmacology · 2026Review
- A Parameterized Cross-Sectional Model for Simulating Balloon Angioplasty in Atherosclerotic Arteries.International journal for numerical methods in biomedical engineering · 2025Article
- Drug-coated balloon treatment for tasc c/d infrapopliteal disease: Two-year matched cohort outcomes.Biomolecules & biomedicine · 2025Article
- Sirolimus coated balloons in peripheral arterial disease, what's next?Cardiovascular diagnosis and therapy · 2025Article
- Real-World 12-Month Outcomes with Sirolimus-Coated Balloon Angioplasty for Complex Femoropopliteal Disease.Journal of clinical medicine · 2025Article
- Peripheral artery disease and local drug delivery: a review of disease pathology and drug delivery systems for therapy below the knee.Experimental biology and medicine (Maywood, N.J.) · 2025Review
- The Utility of Sirolimus Eluting Balloons in the Setting of Chronic Limb Threatening Ischaemia in Asian Patients from Singapore - 12 Months Results of the PRISTINE Registry.Cardiovascular and interventional radiology · 2024Observational
- Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries.Journal of clinical medicine · 2024Review
- Surgical and Endovascular Therapies for Below-the-Knee Peripheral Arterial Disease: A Contemporary Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Review
- Treatment of Peripheral Artery Disease Using Injectable Biomaterials and Drug-Coated Balloons: Safety and Efficacy Perspective.Pharmaceutics · 2023Article
- Utility of sirolimus coated balloons in the peripheral vasculature - a review of the current literature.CVIR endovascular · 2022Review
- Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia-a case series.Quantitative imaging in medicine and surgery · 2022Article
- Utility of the selution SLR™ sirolimus eluting balloon to rescue failing arterio-venous fistulas - 12 month results of the ISABELLA Registry from Singapore.CVIR endovascular · 2022Article
- Combination therapy using scoring and sirolimus drug-coated balloons during lower limb endovascular revascularization for chronic limb threatening ischaemia: A case series.SAGE open medical case reports · 2022Article
Corrections and comments
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Authors and funding
8 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe 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
methodsPRESTIGE 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).
resultsA 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.
conclusionsSelution 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.
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