Prevail Global Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
Other trials for the same condition
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