| NCT ID | NCT06535854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medtronic Vascular |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,205 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,205 participants in total. It began in 2025-02-24 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Eligibility 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
Contact & Investigator
David Kandzari
PRINCIPAL INVESTIGATOR
Piedmont Heart Institute
Frequently Asked Questions
Who can join the NCT06535854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06535854 currently recruiting?
Yes, NCT06535854 is actively recruiting participants. Contact the research team at rs.prevailglobal@medtronic.com for enrollment information.
Where is the NCT06535854 trial being conducted?
This trial is being conducted at Birmingham, United States, Birmingham, United States, Huntsville, United States, Tucson, United States and 11 additional locations.
Who is sponsoring the NCT06535854 clinical trial?
NCT06535854 is sponsored by Medtronic Vascular. The principal investigator is David Kandzari at Piedmont Heart Institute. The trial plans to enroll 1,205 participants.