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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC

About this trial

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 criteria

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Percutaneous Coronary Intervention with DCB and DAPT

Treatment groups

501 Participants
are divided into 1 treatment group

Locations

19
Italy
Clinica Mediterranea08122, Naples Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello90146, Palermo Italy
Portugal
Ulslo-H.Santa Cruz Carnaxide Portugal
ULS Santa Maria Lisbon Portugal

Sponsors and collaborators

Fundación EPIC

Lead sponsor