Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry

Обзор

Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR (in-stent restenosis) in all settings, in order to evaluate its effectiveness and safety. The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.

Подробное описание

Selution Iberia registry is a post-market clinical follow-up, prospective, multicenter, international, longitudinal, observational study without a control group of consecutive unselected "real-world" patients with coronary artery disease in whom it was decided to use the SELUTION SLRTM device in the treatment of primary native lesions and ISR in all settings, in order to evaluate its effectiveness and safety.

The primary objective is to evaluate the effectiveness and safety of the Sirolimus-eluting balloon SELUTION SLRTM based strategy in the treatment of native coronary artery stenosis and in-stent restenosis. The primary endpoint will be the incidence of major adverse cardiovascular events at 12 months, including death, non-fatal myocardial infarction or target lesion revascularization for ischemia, in an unselected "real-world" patient setting. Both Device Oriented Composite Endpoint (Cardiovascular death, device failure-related myocardial infarction or device failure-related ischaemia) and Patient Oriented Composite Endpoint (all cause death, any stroke, any myocardial infarction or any revascularization) will be detailed.

Вмешательства

• Устройство SELUTION SLRTM sirolimus coated balloon
  Patients in whom treatment with SELUTION SLRTM sirolimus coated balloon has been attempted

Первичные конечные точки

• MACE (Major Adverse Cardiovascular Events) [Срок оценки: 12 months]
• TLR [Срок оценки: 12 months]
• DoCE (Device-oriented Composite Endpoint) [Срок оценки: 12 months]
• PoCE (Patient-oriented Composite Endpoint) [Срок оценки: 12 months]

Вторичные конечные точки (9)

• TLR in ISR [Срок оценки: 12 months]
• TLR in primary lesions in native vessel [Срок оценки: 12 months]
• TLR in bifurcation side branch lesions [Срок оценки: 12 months]
• MACE (Major Adverse Cardiovascular Events) in ISR [Срок оценки: 12 months]
• MACE (Major Adverse Cardiovascular Events) in primary lesions in native vessel [Срок оценки: 12 months]
• MACE (Major Adverse Cardiovascular Events) in bifurcation side branch lesions [Срок оценки: 12 months]
• Procedure success [Срок оценки: 1 day]
• Death [Срок оценки: 12 months]
• Non fatal Myocardial Infarction [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients with age ≥18 years and;
• Patients with coronary artery disease in whom, at the operator's discretion, treatment of a lesion in a native vessel, coronary graft or coronary restenosis is decided using the Selution SLRTM device;
• Patient who has been informed of the characteristics of the study and has provided written informed consent.

Критерии исключения

• Express refusal of the patient to participate in the study
• Life expectancy of the patient of less than 12 months

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Испания · 10 центров

• Hospital Universitario de Pontevedra — Vilagarcía de Arousa
• Hospital Universitari Germans Trias i Pujol — Badalona
• Hospital del Mar — Barcelona
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitario de Canarias — San Cristóbal de La Laguna
• Hospital Universitario Marqués de Valdecilla — Santander
• Hospital Clinico Universitario de Santiago — Santiago de Compostela
• Hospital Universitario Virgen del Rocio — Seville
• … и ещё 2 центра

Португалия · 3 центра

• Hospital Prof. Doutor Fernando da Fonseca — Amadora
• Hospital de Santa Cruz — Carnaxide
• Hospital de Faro — Faro

Публикации

• Rittger H, Brachmann J, Sinha AM, Waliszewski M, Ohlow M, Brugger A, Thiele H, Birkemeyer R, Kurowski V, Breithardt OA, Schmidt M, Zimmermann S, Lonke S, von Cranach M, Nguyen TV, Daniel WG, Wohrle J. A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study. J Am Coll Cardio PMID 22386286
• Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 S PMID 30170854
• Costa RA, Mandal SC, Hazra PK, Chopda M, Chandra P, Damiani LP, Abizaid A, Hiremath S. Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions. Cardiovasc Revasc Med. 2022 Dec;45:18-25. doi: 10.1016/j.carrev.2022.08.037. Epub 2022 Sep 5. PMID 36192319
• Madanchi M, Cioffi GM, Attinger-Toller A, Seiler T, Somm S, Koch T, Tersalvi G, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Levine MB, Garcia-Garcia HM, Bossard M, Cuculi F. Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon. Cardiol J. 2022;29(6):906-916. doi: 10.5603/CJ.a2022.0106. Epub 2022 Nov 17. PMID 36385601
• Spaulding C, Krackhardt F, Bogaerts K, Urban P, Meis S, Morice MC, Eccleshall S. Comparing a strategy of sirolimus-eluting balloon treatment to drug-eluting stent implantation in de novo coronary lesions in all-comers: Design and rationale of the SELUTION DeNovo Trial. Am Heart J. 2023 Apr;258:77-84. doi: 10.1016/j.ahj.2023.01.007. Epub 2023 Jan 13. PMID 36642225

Идентификаторы

NCT: NCT07256249 · rEPIC16- SELUTION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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