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Prevail Global Study

Recruiting

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).

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Medtronic Vascular · Participants: 1,205 · Started: Feb 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06535854

Locations in the U.S.

AlabamaThe University of Alabama at Birmingham, Birmingham
Huntsville Hospital, Huntsville
ArizonaCarondelet Saint Marys, Tucson
ArkansasJohn L McClellan Memorial Veterans Hospital, Little Rock
CaliforniaStanford Hospital & Clinics, Stanford
ColoradoMedical Center of the Rockies, Loveland
District of ColumbiaMedstar Washington Hospital Center, Washington D.C.
FloridaBayCare Health System, Clearwater
North Florida Regional Medical Center, Gainesville
University of Miami Hospital, Miami
GeorgiaEmory University Hospital Midtown, Atlanta
Piedmont Atlanta Hospital, Atlanta
IllinoisAdvocate Illinois Masonic Medical Center, Chicago
Midwest Cardiovascular Institute, Naperville
IndianaParkview Health, Fort Wayne
KansasUniversity of Kansas Medical Center, Kansas City
Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist), Overland Park
Ascension Via Christi Saint Francis, Wichita
KentuckySaint Elizabeth Healthcare, Edgewood
MichiganUniversity of Michigan Health System - University Hospital, Ann Arbor
Corewell Health, Grand Rapids
Saint Joseph Mercy Ann Arbor, Ypsilanti
MinnesotaM Health Fairview Clinic, Edina
CentraCare Heart & Vascular Center MN - Saint Cloud Hospital, Saint Cloud
MissouriSaint Lukes Mid America Heart Institute, Kansas City
MontanaProvidence Saint Patrick Hospital, Missoula
New JerseyVirtua Our Lady of Lourdes Hospital, Camden
The Valley Hospital, Paramus
New YorkKaleida Health, Buffalo
Cumc/Nyph, New York
Montefiore Medical Center, New York
Saint Francis Hospital (Roslyn NY), Roslyn
North CarolinaThe Moses H Cone Memorial Hospital, Greensboro
Novant Health New Hanover Regional Medical Center, Wilmington
OhioThe Lindner Research Center, Cincinnati
University Hospitals Cleveland Medical Center, Cleveland
OhioHealth Riverside Methodist Hospital, Columbus
OregonOregon Health & Science University Hospital, Portland
PennsylvaniaLehigh Valley Hospital - Cedar Crest, Allentown
UPMC Pinnacle Harrisburg Campus, Harrisburg
Hospital of the University of Pennsylvania, Philadelphia
Rhode IslandRhode Island Hospital and Health Services - Lifespan, Providence
South CarolinaAnMed Health Medical Center, Anderson
Medical University of South Carolina (MUSC), Charleston
TennesseeTriStar Centennial Medical Center, Nashville
Vanderbilt University Medical Center, Nashville
TexasBaylor Heart & Vascular Hospital, Dallas
HCA Houston Medical Center, Houston
The Heart Hospital Baylor Plano, Plano
WashingtonUniversity of Washington (UW) Medical Center, Seattle
WisconsinGundersen Lutheran, La Crosse

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.