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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,205
- 试验地点
- 96
- 主要终点
- ISR Cohort Primary Analysis
研究概览
简要总结
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Masking only applies to the subjects in the ISR Cohort, subjects will be randomized at a 1:1 ratio to treatment with the Prevail DCB or the Agent DCB.
Subjects in DNSV Cohort will be prospectively enrolled in the study and treated with Prevail DCB.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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
排除标准
- •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)
- •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
研究组 & 干预措施
ISR Cohort Prevail DCB
To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
干预措施: Prevail DCB (Device)
ISR Cohort Prevail DCB
To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
干预措施: Agent DCB (Device)
DNSV Cohort (RVD 2.0 - 2.75mm)
To evaluate the clinical safety and efficacy of the Prevail DCB as compared to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
干预措施: Prevail DCB (Device)
结局指标
主要结局
ISR Cohort Primary Analysis
时间窗: 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority
DNSV Cohort Primary Analysis
时间窗: 1 year post-procedure
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
次要结局
- Acute success(hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months)
- All deaths(hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months)
- Cardiac death(hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months)
- All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)(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(hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months)
- Clinically-driven target vessel revascularization (cd-TVR)(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(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(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(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(hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months)