Prevail Global Study

Description

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

Conditions

Coronary Artery Disease

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Study Overview

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Study Details

Study overview

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

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).

Prevail Global Study

Condition
Coronary Artery Disease
Intervention / Treatment

-

Contacts and Locations

Roslyn

Saint Francis Hospital (Roslyn NY), Roslyn, New York, United States, 11576

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Vascular,

David Kandzari, PRINCIPAL_INVESTIGATOR, Piedmont Heart Institute

Bruno Scheller, PRINCIPAL_INVESTIGATOR, University of Saarland

Azeem Latib, PRINCIPAL_INVESTIGATOR, Montefiore Health System

Darren Mylotte, PRINCIPAL_INVESTIGATOR, Galway University Hospitals

Study Record Dates

2031-02