Recruiting

Prevail DCBPrevail Global Study

Sponsor:

Medtronic Vascular

Code:

NCT06535854

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prevail DCB

Agent DCB

Study Details

Brief summary:

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

Conditions

Coronary Artery Disease

Study ID

NCT06535854

Start date

Feb 24, 2025

Status verified date

Apr, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1205 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jeroen Frijhoff

+31 (0)43.356.6566 rs.prevailglobal@medtronic.com

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Mustafa Ahmed

Huntsville Hospital

Recruiting

Huntsville, Alabama, United States, 35801

Principal Investigator:

Michael Butler

Carondelet Saint Marys

Recruiting

Tucson, Arizona, United States, 85745

Principal Investigator:

Kapil Lotun

John L McClellan Memorial Veterans Hospital

Recruiting

Little Rock, Arkansas, United States, 72205

Principal Investigator:

Barry Uretsky

Stanford Hospital & Clinics

Recruiting

Stanford, California, United States, 94305

Principal Investigator:

Jennifer Tremmel

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Principal Investigator:

Shivanshu Madan

Medstar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Principal Investigator:

Hayder Hashim

BayCare Health System

Recruiting

Clearwater, Florida, United States, 33756

Principal Investigator:

Parag Patel

North Florida Regional Medical Center

Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator:

Mark Tulli

University of Miami Hospital

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Yiannis Chatzizisis

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator:

Pratik Sandesara

Piedmont Atlanta Hospital

Recruiting

Atlanta, Georgia, United States, 30309

Principal Investigator:

Prashant Kaul

Advocate Illinois Masonic Medical Center

Recruiting

Chicago, Illinois, United States, 60657

Principal Investigator:

Joaquin Gonzalez

Midwest Cardiovascular Institute

Recruiting

Naperville, Illinois, United States, 60540

Principal Investigator:

Mark Goodwin

Parkview Health

Recruiting

Fort Wayne, Indiana, United States, 46845

Principal Investigator:

Peter Chaille

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Principal Investigator:

Anthony (Tony) Spaedy

Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)

Recruiting

Overland Park, Kansas, United States, 66211

Principal Investigator:

Jayasheel Eshcol

Ascension Via Christi Saint Francis

Recruiting

Wichita, Kansas, United States, 67214

Principal Investigator:

Bassem Chehab

Saint Elizabeth Healthcare

Recruiting

Edgewood, Kentucky, United States, 41017

Principal Investigator:

Mohan Brar

University of Michigan Health System - University Hospital

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Daniel Menees

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Principal Investigator:

Araya Negash

Saint Joseph Mercy Ann Arbor

Recruiting

Ypsilanti, Michigan, United States, 48197

Principal Investigator:

Mansoor Qureshi

M Health Fairview Clinic

Recruiting

Edina, Minnesota, United States, 55435

Principal Investigator:

Tim Biring

CentraCare Heart & Vascular Center MN - Saint Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Principal Investigator:

Stephen Kidd

Saint Lukes Mid America Heart Institute

Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator:

Steven Laster

Providence Saint Patrick Hospital

Recruiting

Missoula, Montana, United States, 59802

Principal Investigator:

Daniel Spoon

Virtua Our Lady of Lourdes Hospital

Recruiting

Camden, New Jersey, United States, 08103

Principal Investigator:

Kintur Sanghvi

The Valley Hospital

Recruiting

Paramus, New Jersey, United States, 07652

Principal Investigator:

Rajiv Tayal

Kaleida Health

Recruiting

Buffalo, New York, United States, 14214

Principal Investigator:

Vijay Iyer

Cumc/Nyph

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Mahesh Madhavan

Montefiore Medical Center

Recruiting

New York, New York, United States, 10467

Principal Investigator:

Andrea Mignatti

Saint Francis Hospital (Roslyn NY)

Recruiting

Roslyn, New York, United States, 11576

Principal Investigator:

Evan Shlofmitz

The Moses H Cone Memorial Hospital

Recruiting

Greensboro, North Carolina, United States, 27401

Principal Investigator:

Muhammad Arida

Novant Health New Hanover Regional Medical Center

Recruiting

Wilmington, North Carolina, United States, 28401

Principal Investigator:

Sunil Iyer

The Lindner Research Center

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Jarrod Frizzell

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator:

Bernardo Cortese

OhioHealth Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Principal Investigator:

Arash Arshi

Oregon Health & Science University Hospital

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Firas Zahr

Lehigh Valley Hospital - Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Principal Investigator:

Shai Singh

UPMC Pinnacle Harrisburg Campus

Recruiting

Harrisburg, Pennsylvania, United States, 17101

Principal Investigator:

Randolph Hubbard

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Taisei Kobayashi

Rhode Island Hospital and Health Services - Lifespan

Recruiting

Providence, Rhode Island, United States, 02903

Principal Investigator:

J. Dawn Abbott

AnMed Health Medical Center

Recruiting

Anderson, South Carolina, United States, 29621

Principal Investigator:

John Meehan

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Anbukarasi Maran

TriStar Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

Brian Jefferson

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Colin Barker

Baylor Heart & Vascular Hospital

Recruiting

Dallas, Texas, United States, 75226

Principal Investigator:

Robert Stoler

HCA Houston Medical Center

Recruiting

Houston, Texas, United States, 77004

Principal Investigator:

Pranav Loyalka

The Heart Hospital Baylor Plano

Recruiting

Plano, Texas, United States, 75093

Principal Investigator:

Sibi Thomas

University of Washington (UW) Medical Center

Recruiting

Seattle, Washington, United States, 98195

Principal Investigator:

Lorenzo Azzalini

Gundersen Lutheran

Recruiting

La Crosse, Wisconsin, United States, 54601

Principal Investigator:

Wah Wah Htun

More Information

Sponsor

Medtronic Vascular

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

ISR
DNSV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medtronic Vascular on 2026-04-24.