NCT06321757

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 501 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon 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 PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up. As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months. Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-26
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-03-20
• Last updated: 2026-04-17

Locations

18 sites across 3 countries: Italy, Portugal, Spain