MedTrace Logo

Prevail Global Study

NCT06535854 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1205

Last updated 2026-04-24

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

Prevail DCB

The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.

DEVICE

Agent DCB

The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).

Sponsors & Collaborators

  • Medtronic Vascular

    lead INDUSTRY

Principal Investigators

  • David Kandzari · Piedmont Heart Institute

  • Bruno Scheller · University of Saarland

  • Azeem Latib · Montefiore Health System

  • Darren Mylotte · Galway University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2027-02-28
Completion
2031-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06535854 on ClinicalTrials.gov