Prevail Global Study

April 21, 2026 updated by: Medtronic Vascular

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ISR Cohort Primary Analysis
Time Frame: 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
1 year post-procedure
DNSV Cohort Primary Analysis
Time Frame: 1 year post-procedure
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute success
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Cardiac death
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Clinically-driven target vessel revascularization (cd-TVR)
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
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
Time Frame: hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Vascular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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