Prevail Global Study

Официальное название

A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).

Обзор

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Подробное описание

The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.

In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.

Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.

Вмешательства

• Устройство Prevail DCB
  The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
• Устройство Agent DCB
  The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).

Первичные конечные точки

• ISR Cohort Primary Analysis [Срок оценки: 1 year post-procedure]
• DNSV Cohort Primary Analysis [Срок оценки: 1 year post-procedure]

Вторичные конечные точки (10)

• Acute success [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• All deaths [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Cardiac death [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• All myocardial infarction (MI), including target vessel myocardial infarction (TVMI) [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Clinically-driven target vessel revascularization (cd-TVR) [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition [Срок оценки: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]

Критерии участия

Критерии включения

• ≥ 18 years
• Negative pregnancy test
• Stable or unstable angina, positive functional test, or stable NSTEMI
• Life expectancy >1 year
• Willing and able to cooperate with study procedures and required follow up evaluations

Критерии исключения

• Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
• History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
• Platelet count < 100,000 cells/mm³ or > 700,000 cells/mm³, or a white blood cell (WBC) count < 3,000 cells/mm³
• Renal insufficiency (or failure)
• Acute MI
• Previous PCI of the target vessel within 6 months prior to the procedure
• Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
• History of a stroke or transient ischemic attack (TIA)
• Active peptic ulcer or upper gastrointestinal (GI) bleeding
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Documented left ventricular ejection fraction (LVEF) <30%
• Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
• Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 51 центр

• The University of Alabama at Birmingham — Birmingham
• Huntsville Hospital — Huntsville
• Carondelet Saint Marys — Tucson
• John L McClellan Memorial Veterans Hospital — Little Rock
• Stanford Hospital & Clinics — Stanford
• Medical Center of the Rockies — Loveland
• Medstar Washington Hospital Center — Washington D.C.
• BayCare Health System — Clearwater
• … и ещё 43 центра

Публикации

• Kandzari DE, Latib A, Mylotte D, Ali ZA, Zaman A, Brar S, Parke M, Scheller B. Rationale and design of the prevail global trial program evaluating the prevail drug-coated balloon in patients with in-stent restenosis and de novo small vessel disease. Am Heart J. 2025 May;283:26-36. doi: 10.1016/j.ahj.2025.01.010. Epub 2025 Jan 23. PMID 39863032

Идентификаторы

NCT: NCT06535854 · MDT22021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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