PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
ConditionCoronary Artery Disease
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 groupSponsors and collaborators
Source ClinicalTrials.gov