SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters

Обзор

The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or paclitaxel coated DCBs (see Table 1), irrespective of clinical presentation as well as to prospectively collect data about their clinical outcomes. Outcomes will be compared in different clinical subgroups. The impact of current DCBs in different clinical settings and coronary artery lesions on cardiovascular outcomes will be assessed.

Подробное описание

Objectives in detail:

* To evaluate procedural success, efficacy, performance and clinical outcomes among various patient cohorts, who undergo PCI using currently available DCBs:

1. Periprocedural outcomes/complications, which will be analyzed, include: final result (e.g. residual stenosis, TIMI flow), dissections, perforations, prevalence of thrombus (assessed by angiography and intravascular imaging) 2. Short and long-term clinical outcomes of interest comprise among others: new MI, unstable angina (UA), target lesion failure, target vessel revascularization, target lesion failure/ revascularization, repeat hospitalization, new/worsening heart failure, cardiogenic shock, stroke, bleedings, cardiovascular death and all-cause death. * To describe procedural and clinical performance of various DCB, either alone or in combination with other stent and coronary scaffold devices * To identify optimal strategies for lesion preparation in cases treated with DCB * To identify possible predictors for TLR after treatment with DCB * To describe early and late angiographic and OCT-findings among coronary artery disease (CAD) patients treated with DCB and/or various metallic stent and scaffold devices * To evaluate the impact of different antithrombotic regimens on patient's clinical outcomes * To study procedural and clinical outcomes among CAD patients requiring hemodynamic support using mechanical devices. * To describe economic implications (cost-effectiveness) of various interventional treatments for CAD.

Вмешательства

• Устройство Sirolimus Eluting Balloon
  PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon

Первичные конечные точки

• Rate of target lesion failure (TLF) and target lesion revascularization (TLR) [Срок оценки: at 1 year]

Вторичные конечные точки (12)

• Rate of combination of major adverse cardiac and cerebrovascular events (MACCE) (including new MI, TLR or cardiovascular death) [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of MACE [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of new MI (NSTEMI / STEMI) [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of TIA or stroke [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of acute vessel closure [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of stent thrombosis or ISR [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of target vessel revascularization (TVR) [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of target lesion revascularization (TLR) [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of target lesion failure (TLF) [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of ischemia driven TLR [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of all-cause death [Срок оценки: at 180 days, 1, 2 and 5 years]
• Rate of cardiac death [Срок оценки: at 180 days, 1, 2 and 5 years]

Критерии участия

Критерии включения

• Subject >18 years of age
• Patients with significant acute or chronic coronary de-novo lesions or ISR lesions requiring treatment using PCI
• Treatment with at least one DCB (device choice at the operator's discretion) In case of a patient with lesions treated at different procedural time, lesions will be separately collected and documented
• Subjects must be willing to sign a patient informed consent (PIC) or must have signed the General Consent (GK).

Критерии исключения

• Patient is <18 years of age
• Patient unwilling or unable to provide informed consent
• pregnancy and lactation
• Indication for surgical revascularization

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Luzerner Heart Centre — Lucerne

Публикации

• Cioffi GM, Madanchi M, Attinger-Toller A, Bossard M, Cuculi F. Pushing the Boundaries: Drug-Coated Balloons to Treat a Calcified and Thrombotic Lesion in Acute Coronary Syndrome. Am J Case Rep. 2022 Oct 5;23:e936950. doi: 10.12659/AJCR.936950. PMID 36196027
• 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
• Madanchi M, Attinger-Toller A, Gjergjizi V, Majcen I, Cioffi GM, Epper A, Gnan E, Koch T, Zhi Y, Cuculi F, Bossard M. Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon. Front Cardiovasc Med. 2024 Feb 13;11:1316580. doi: 10.3389/fcvm.2024.1316580. eCollection 2024. PMID 38414923
• Madanchi M, Bossard M, Majcen I, Cioffi GM, Ferraro F, Gnan E, Gjergjizi V, Zhi Y, Bade V, Wolfrum M, Moccetti F, Toggweiler S, Attinger-Toller A, Cuculi F. Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons. J Invasive Cardiol. 2024 Mar;36(3). doi: 10.25270/jic/23.00260. PMID 38441987

Идентификаторы

NCT: NCT04988685 · 2021-00615

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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