Prevail Global Study

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).

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Prevail DCB; Device: Agent 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.

• Study Type: Interventional
• Enrollment (Estimated): 1205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeroen Frijhoff; Phone Number: +31 (0)43.356.6566; Email: rs.prevailglobal@medtronic.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • The University of Alabama at Birmingham
      • Principal Investigator: Mustafa Ahmed
    • Huntsville, Alabama, United States, 35801
      • Recruiting
      • Huntsville Hospital
      • Principal Investigator: Michael Butler
  • Arizona
    • Tucson, Arizona, United States, 85745
      • Recruiting
      • Carondelet Saint Marys
      • Principal Investigator: Kapil Lotun
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • John L McClellan Memorial Veterans Hospital
      • Principal Investigator: Barry Uretsky
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Hospital & Clinics
      • Principal Investigator: Jennifer Tremmel
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Recruiting
      • Medical Center of the Rockies
      • Principal Investigator: Shivanshu Madan
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center
      • Principal Investigator: Hayder Hashim
  • Florida
    • Clearwater, Florida, United States, 33756
      • Recruiting
      • BayCare Health System
      • Principal Investigator: Parag Patel
    • Gainesville, Florida, United States, 32605
      • Recruiting
      • North Florida Regional Medical Center
      • Principal Investigator: Mark Tulli
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospital
      • Principal Investigator: Yiannis Chatzizisis
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Recruiting
      • Emory University Hospital Midtown
      • Principal Investigator: Pratik Sandesara
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Atlanta Hospital
      • Principal Investigator: Prashant Kaul
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Recruiting
      • Advocate Illinois Masonic Medical Center
      • Principal Investigator: Joaquin Gonzalez
    • Naperville, Illinois, United States, 60540
      • Recruiting
      • Midwest Cardiovascular Institute
      • Principal Investigator: Mark Goodwin
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
      • Parkview Health
      • Principal Investigator: Peter Chaille
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Anthony (Tony) Spaedy
    • Overland Park, Kansas, United States, 66211
      • Recruiting
      • Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist)
      • Principal Investigator: Jayasheel Eshcol
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Ascension Via Christi Saint Francis
      • Principal Investigator: Bassem Chehab
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • Recruiting
      • Saint Elizabeth Healthcare
      • Principal Investigator: Mohan Brar
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health System - University Hospital
      • Principal Investigator: Daniel Menees
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health
      • Principal Investigator: Araya Negash
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • Saint Joseph Mercy Ann Arbor
      • Principal Investigator: Mansoor Qureshi
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Recruiting
      • M Health Fairview Clinic
      • Principal Investigator: Tim Biring
    • Saint Cloud, Minnesota, United States, 56303
      • Recruiting
      • CentraCare Heart & Vascular Center MN - Saint Cloud Hospital
      • Principal Investigator: Stephen Kidd
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Saint Lukes Mid America Heart Institute
      • Principal Investigator: Steven Laster
  • Montana
    • Missoula, Montana, United States, 59802
      • Recruiting
      • Providence Saint Patrick Hospital
      • Principal Investigator: Daniel Spoon
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Virtua Our Lady of Lourdes Hospital
      • Principal Investigator: Kintur Sanghvi
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • The Valley Hospital
      • Principal Investigator: Rajiv Tayal
      • Contact: Kimberley Michel
  • New York
    • Buffalo, New York, United States, 14214
      • Recruiting
      • Kaleida Health
      • Principal Investigator: Vijay Iyer
    • New York, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: Andrea Mignatti
    • New York, New York, United States, 10032
      • Recruiting
      • Cumc/Nyph
      • Contact: Katie Dalton
      • Principal Investigator: Mahesh Madhavan
    • Roslyn, New York, United States, 11576
      • Recruiting
      • Saint Francis Hospital (Roslyn NY)
      • Contact: Elizabeth Haag
      • Contact: Marion Cyriac
      • Principal Investigator: Evan Shlofmitz
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Recruiting
      • The Moses H Cone Memorial Hospital
      • Principal Investigator: Muhammad Arida
    • Wilmington, North Carolina, United States, 28401
      • Recruiting
      • Novant Health New Hanover Regional Medical Center
      • Principal Investigator: Sunil Iyer
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • The Lindner Research Center
      • Principal Investigator: Jarrod Frizzell
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Principal Investigator: Bernardo Cortese
    • Columbus, Ohio, United States, 43214
      • Recruiting
      • OhioHealth Riverside Methodist Hospital
      • Principal Investigator: Arash Arshi
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University Hospital
      • Principal Investigator: Firas Zahr
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Recruiting
      • Lehigh Valley Hospital - Cedar Crest
      • Principal Investigator: Shai Singh
    • Harrisburg, Pennsylvania, United States, 17101
      • Recruiting
      • UPMC Pinnacle Harrisburg Campus
      • Principal Investigator: Randolph Hubbard
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Principal Investigator: Taisei Kobayashi
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital and Health Services - Lifespan
      • Principal Investigator: J. Dawn Abbott
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Recruiting
      • AnMed Health Medical Center
      • Principal Investigator: John Meehan
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina (MUSC)
      • Principal Investigator: Anbukarasi Maran
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • Vanderbilt University Medical Center
      • Principal Investigator: Colin Barker
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • TriStar Centennial Medical center
      • Principal Investigator: Brian Jefferson
  • Texas
    • Dallas, Texas, United States, 75226
      • Recruiting
      • Baylor Heart & Vascular Hospital
      • Principal Investigator: Robert Stoler
    • Houston, Texas, United States, 77004
      • Recruiting
      • HCA Houston Medical Center
      • Principal Investigator: Pranav Loyalka
    • Plano, Texas, United States, 75093
      • Recruiting
      • The Heart Hospital Baylor Plano
      • Principal Investigator: Sibi Thomas
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington (UW) Medical Center
      • Principal Investigator: Lorenzo Azzalini
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Recruiting
      • Gundersen Lutheran
      • Principal Investigator: Wah Wah Htun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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).
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ISR Cohort Primary Analysis	The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority	1 year post-procedure
DNSV Cohort Primary Analysis	The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control	1 year post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute success	Acute success (device, lesion, and procedure) through hospital discharge only	hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All deaths		hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Cardiac death		hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)		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		hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target vessel revascularization (cd-TVR)		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		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		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		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		hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Investigators: Principal Investigator: David Kandzari, Piedmont Heart Institute; Principal Investigator: Bruno Scheller, University of Saarland; Principal Investigator: Azeem Latib, Montefiore Health System; Principal Investigator: Darren Mylotte, Galway University Hospitals

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2031

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: July 30, 2024
• First Posted (Actual): August 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ISR; DNSV
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: MDT22021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No