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PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients

NCT06321757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 501

Last updated 2026-04-17

No results posted yet for this study

Summary

Post-market, prospective, observational, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon (DCB)therapy in real-world patients with small native vessel coronary artery disease, and to demonstrate the safety of short dual antiplatelet therapy (7 days) in high-bleeding risk patients with native small vessel coronary artery disease treated with DCB therapy. A percutaneous coronary intervention (PCI) with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician.

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention with DCB and DAPT

* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT

Sponsors & Collaborators

  • Fundación EPIC

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-26
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • Italy
  • Portugal
  • Spain

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 NCT06321757 on ClinicalTrials.gov