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RECRUITING
NCT06321757

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

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

501

Start Date

2024-02-26

Completion Date

2026-12-30

Last Updated

2025-12-19

Healthy Volunteers

No

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

Locations (17)

Ulslo-H.Santa Cruz

Carnaxide, Portugal

ULS Santa Maria

Lisbon, Portugal

Hospital General Universitario de Albacete

Albacete, Spain

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

University Hospital HM Montepríncipe

Boadilla del Monte, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Hospital Universitario Clinico San Cecilio

Granada, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitario de La Princesa

Madrid, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain