Ireland
--:--IST
Recruiting Not applicable

Prevail Global Study

NCT06535854 · tracked via the Priya Life Science Japan tracker
Phase
Not applicable
Started
2025-02-24
Last updated
2026-04-24

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Prevail DCBAgent DCB

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.

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).

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • ISR Cohort Primary Analysis — 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 — 1 year post-procedure
    The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control

Trial sites (51)

FacilityCityRegionStatus
The University of Alabama at Birmingham Birmingham Alabama Recruiting
Huntsville Hospital Huntsville Alabama Recruiting
Carondelet Saint Marys Tucson Arizona Recruiting
John L McClellan Memorial Veterans Hospital Little Rock Arkansas Recruiting
Stanford Hospital & Clinics Stanford California Recruiting
Medical Center of the Rockies Loveland Colorado Recruiting
Medstar Washington Hospital Center Washington D.C. District of Columbia Recruiting
BayCare Health System Clearwater Florida Recruiting
North Florida Regional Medical Center Gainesville Florida Recruiting
University of Miami Hospital Miami Florida Recruiting
Emory University Hospital Midtown Atlanta Georgia Recruiting
Piedmont Atlanta Hospital Atlanta Georgia Recruiting
Advocate Illinois Masonic Medical Center Chicago Illinois Recruiting
Midwest Cardiovascular Institute Naperville Illinois Recruiting
Parkview Health Fort Wayne Indiana Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) Overland Park Kansas Recruiting
Ascension Via Christi Saint Francis Wichita Kansas Recruiting
Saint Elizabeth Healthcare Edgewood Kentucky Recruiting
University of Michigan Health System - University Hospital Ann Arbor Michigan Recruiting
Corewell Health Grand Rapids Michigan Recruiting
Saint Joseph Mercy Ann Arbor Ypsilanti Michigan Recruiting
M Health Fairview Clinic Edina Minnesota Recruiting
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital Saint Cloud Minnesota Recruiting
Saint Lukes Mid America Heart Institute Kansas City Missouri Recruiting
Providence Saint Patrick Hospital Missoula Montana Recruiting
Virtua Our Lady of Lourdes Hospital Camden New Jersey Recruiting
The Valley Hospital Paramus New Jersey Recruiting
Kaleida Health Buffalo New York Recruiting
Cumc/Nyph New York New York Recruiting
Montefiore Medical Center New York New York Recruiting
Saint Francis Hospital (Roslyn NY) Roslyn New York Recruiting
The Moses H Cone Memorial Hospital Greensboro North Carolina Recruiting
Novant Health New Hanover Regional Medical Center Wilmington North Carolina Recruiting
The Lindner Research Center Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
OhioHealth Riverside Methodist Hospital Columbus Ohio Recruiting
Oregon Health & Science University Hospital Portland Oregon Recruiting
Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania Recruiting
UPMC Pinnacle Harrisburg Campus Harrisburg Pennsylvania Recruiting

+ 11 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06535854 on ClinicalTrials.gov ↗ ← All trials in Japan