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Prevail Global Study

RecruitingNAAges 18 Years - anyAllMedtronic Vascular
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Prevail DCB
  • Agent DCB
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Where

79 sites
Cardiology P.C.
Birmingham, United States
The University of Alabama at Birmingham
Birmingham, United States
Huntsville Hospital
Huntsville, United States
Carondelet Saint Marys
Tucson, United States
John L McClellan Memorial Veterans Hospital
Little Rock, United States
Stanford Hospital & Clinics
Stanford, United States
Medical Center of the Rockies
Loveland, United States
Medstar Washington Hospital Center
Washington D.C., United States

…and 71 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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