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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

This trial does not accept healthy volunteers

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 population

drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Coronary Intervention with DCB and DAPT

    Device

    * Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) * Patients with PCI (DCB) + short DAPT

Treatment groups

501 Participants
are divided into 1 treatment group
Group A: Patients with small native vessel coronary artery disease1 intervention

Trial outcomes

Primary outcomes

1

Effectiveness of DCB therapy

Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion

Time frame
1 year

Secondary outcomes

1

Cardiac death

Incidence of Cardiac death

Time frame
1 year
2

All-cause mortality

Incidence of All-cause mortality

Time frame
1 year
3

Target vessel myocardial infarction

Incidence of Target vessel myocardial infarction

Time frame
1 year
4

New target lesion revascularization (TLR)

Incidence of New target lesion revascularization (TLR)

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación EPIC

Lead sponsor

Source ClinicalTrials.gov
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