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Recruiting

Prevail Global Study

Medtronic Vascular · NCT06535854

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
1205
US sites recruiting
54
Study start
February 24, 2025
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Prevail DCB; Agent DCB

Conditions: Coronary Artery Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 72 hours 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

Recruiting US locations

  • Cardiology P.C.

    Birmingham, AL 35211

    Site contact: Tushar Mishra

  • The University of Alabama at Birmingham

    Birmingham, AL 35294

    Site contact: Mustafa Ahmed

  • Huntsville Hospital

    Huntsville, AL 35801

    Site contact: Michael Butler

  • Carondelet Saint Marys

    Tucson, AZ 85745

    Site contact: Kapil Lotun

  • John L McClellan Memorial Veterans Hospital

    Little Rock, AR 72205

    Site contact: Barry Uretsky

  • Stanford Hospital & Clinics

    Stanford, CA 94305

    Site contact: Jennifer Tremmel

  • Medical Center of the Rockies

    Loveland, CO 80538

    Site contact: Shivanshu Madan

  • Medstar Washington Hospital Center

    Washington D.C., DC 20010

    Site contact: Hayder Hashim

  • BayCare Health System

    Clearwater, FL 33756

    Site contact: Parag Patel

  • North Florida Regional Medical Center

    Gainesville, FL 32605

    Site contact: Mark Tulli

  • University of Miami Hospital

    Miami, FL 33136

    Site contact: Yiannis Chatzizisis

  • Emory University Hospital Midtown

    Atlanta, GA 30308

    Site contact: Pratik Sandesara

  • Piedmont Atlanta Hospital

    Atlanta, GA 30309

    Site contact: Prashant Kaul

  • Advocate Illinois Masonic Medical Center

    Chicago, IL 60657

    Site contact: Joaquin Gonzalez

  • Midwest Cardiovascular Institute

    Naperville, IL 60540

    Site contact: Osama Qaqi

  • Parkview Health

    Fort Wayne, IN 46845

    Site contact: Peter Chaille

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Anthony (Tony) Spaedy

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

    Overland Park, KS 66211

    Site contact: Jayasheel Eshcol

  • Ascension Via Christi Saint Francis

    Wichita, KS 67214

    Site contact: Bassem Chehab

  • Saint Elizabeth Healthcare

    Edgewood, KY 41017

    Site contact: Mohan Brar

  • Norton Heart and Vascular Institute

    Louisville, KY 40205

    Site contact: Sean Stewart

  • University of Michigan Health System - University Hospital

    Ann Arbor, MI 48109

    Site contact: Daniel Menees

  • Corewell Health

    Grand Rapids, MI 49503

    Site contact: Araya Negash

  • Saint Joseph Mercy Ann Arbor

    Ypsilanti, MI 48197

    Site contact: Mansoor Qureshi

  • Abbott Northwestern Hospital

    Minneapolis, MN 55407

    Site contact: Konstantinos Voudris

  • CentraCare Heart & Vascular Center MN - Saint Cloud Hospital

    Saint Cloud, MN 56303

    Site contact: Stephen Kidd

  • Saint Lukes Mid America Heart Institute

    Kansas City, MO 64111

    Site contact: Dany Jacob

  • Providence Saint Patrick Hospital

    Missoula, MT 59802

    Site contact: Michael Reed

  • Virtua Our Lady of Lourdes Hospital

    Camden, NJ 08103

    Site contact: Kintur Sanghvi

  • The Valley Hospital

    Paramus, NJ 07652

    Site contact: Kimberley Michel

  • Kaleida Health

    Buffalo, NY 14214

    Site contact: Vijay Iyer

  • Northwell Health North Shore University Hospital

    Manhasset, NY 11030

    Site contact: Avneet Singh

  • Cumc/Nyph

    New York, NY 10032

    Site contact: Ajay Kirtane

  • Montefiore Medical Center

    New York, NY 10467

    Site contact: Andrea Mignatti

  • Saint Francis Hospital (Roslyn NY)

    Roslyn, NY 11576

    Site contact: Elizabeth Haag

  • The Moses H Cone Memorial Hospital

    Greensboro, NC 27401

    Site contact: Muhammad Arida

  • Novant Health New Hanover Regional Medical Center

    Wilmington, NC 28401

    Site contact: Sunil Iyer

  • The Lindner Research Center

    Cincinnati, OH 45219

    Site contact: Jarrod Frizzell

  • University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Anjan Gupta

  • OhioHealth Riverside Methodist Hospital

    Columbus, OH 43214

    Site contact: Arash Arshi

  • Oregon Health & Science University Hospital

    Portland, OR 97239

    Site contact: Firas Zahr

  • Lehigh Valley Hospital - Cedar Crest

    Allentown, PA 18103

    Site contact: Shai Singh

  • UPMC Pinnacle Harrisburg Campus

    Harrisburg, PA 17101

    Site contact: Randolph Hubbard

  • Hospital of the University of Pennsylvania

    Philadelphia, PA 19104

    Site contact: Taisei Kobayashi

  • Rhode Island Hospital and Health Services - Lifespan

    Providence, RI 02903

    Site contact: Saraschandra Vallabhajosyula

  • AnMed Health Medical Center

    Anderson, SC 29621

    Site contact: John Meehan

  • Medical University of South Carolina (MUSC)

    Charleston, SC 29425

    Site contact: Christopher Nielsen

  • TriStar Centennial Medical Center

    Nashville, TN 37203

    Site contact: Brian Jefferson

  • Vanderbilt University Medical Center

    Nashville, TN 37232

    Site contact: Colin Barker

  • Baylor Heart & Vascular Hospital

    Dallas, TX 75226

    Site contact: Robert Stoler

  • HCA Houston Medical Center

    Houston, TX 77004

    Site contact: Pranav Loyalka

  • The Heart Hospital Baylor Plano

    Plano, TX 75093

    Site contact: Sibi Thomas

  • University of Washington (UW) Medical Center

    Seattle, WA 98195

    Site contact: Lorenzo Azzalini

  • Gundersen Lutheran

    La Crosse, WI 54601

    Site contact: Wah Wah Htun

Study contacts (from the official record)

  • Jeroen Frijhoff · +31 (0)43.356.6566 · rs.prevailglobal@medtronic.com
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Prevail Global Study (NCT06535854) | Bored Studies