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PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Sponsor: Fundación EPIC
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
Conditions
Interventions
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