Prevail Global Study

Official title

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).

Overview

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

Detailed description

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.

Interventions

• Device 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.
• Device 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).

Primary outcome measures

• ISR Cohort Primary Analysis [Time frame: 1 year post-procedure]
• DNSV Cohort Primary Analysis [Time frame: 1 year post-procedure]

Secondary outcome measures (10)

• Acute success [Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• All deaths [Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Cardiac death [Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• All myocardial infarction (MI), including target vessel myocardial infarction (TVMI) [Time frame: 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 [Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]
• Clinically-driven target vessel revascularization (cd-TVR) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months]

Eligibility criteria

Inclusion criteria

• ≥ 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 51 centers

• 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
• … and 43 more centers

Publications

• 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

Identifiers

NCT: NCT06535854 · MDT22021

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗