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Evaluating a new drug-coated balloon for coronary artery disease

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).

Not applicable Interventional Medtronic Vascular · NCT06535854

This study is testing a new drug-coated balloon to see if it can help people with coronary artery disease, including those with previous stent issues and those with new small vessel problems.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1205 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Vascular Industry-sponsored
Locations51 sites (Birmingham, Alabama and 50 other locations)
Trial IDNCT06535854 on ClinicalTrials.gov

What this trial studies

The Prevail Global study is a prospective, multi-center clinical evaluation of the Prevail Drug-Coated Balloon (DCB) for treating coronary artery disease. It includes two cohorts: one for patients with in-stent restenosis (ISR) who will be randomized to receive either the Prevail DCB or an Agent DCB, and another for patients with de novo lesions in small vessel disease (DNSV) who will receive the Prevail DCB in a single-arm study. The study aims to assess the safety and efficacy of the Prevail DCB compared to historical controls and will follow participants for up to five years. Approximately 65 study sites will be involved in the enrollment process over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable or unstable angina or positive functional tests.

Not a fit: Patients with known hypersensitivity to antiplatelet medications or those with acute myocardial infarction will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with coronary artery disease.

How similar studies have performed: Previous studies have shown promise with drug-coated balloons in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Birmingham, Alabama and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseISRDNSV
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.