PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Fundación EPIC
501 participants
Feb 26, 2024
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Patients with:
- PCI with DCB on native arteries with diameters < 3 mm.
- Indication for PCI in acute coronary syndrome or chronic coronary syndrome or silent angina with an indication for PCI.
- syndrome or silent angina with an indication for PCI.
- If previous lesion preparation was required after which angiographic residual lesion should not exist with diameter stenosis > 30% or flow-limiting coronary dissections.
- All antithrombotic therapies administered prior to the procedure are accepted. Still, they can be changed after the procedure.
- Capacity to understand and sign the written informed consent.
Exclusion Criteria11
- Patients with:
- Concomitant lesions on vessels > 3 mm in diameter in the same coronary territory.
- PCI on in-stent restenoses.
- PCI on culprit lesions of acute coronary syndrome with ST segment elevation.
- Patients with an indication for PCI on additional non-culprit lesions of acute coronary syndrome with ST segment elevation may be included in the study, if only non-culprit lesions are considered for the study.
- Life expectancy <12 months
- Pregnancy.
- Participation in clinicaltrials.
- Inability to give the written informed consent.
- Past medical history of stent thrombosis.
- Indication for dual antiplatelet therapy for a different reason.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT
Locations(18)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06321757