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Using a paclitaxel-coated balloon for treating small coronary artery disease in high-bleeding risk patients

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

Observational Fundación EPIC · NCT06321757

This study is testing if a special balloon treatment can help people with small coronary artery disease who are at high risk for bleeding during heart procedures.

Quick facts

Study typeObservational
Enrollment501 (estimated)
Ages18 Years and up
SexAll
SponsorFundación EPIC Academic / other
Locations18 sites (Naples and 17 other locations)
Trial IDNCT06321757 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of drug-coated balloon (DCB) therapy in patients with small native vessel coronary artery disease. It will also assess the safety of a short dual antiplatelet therapy regimen in high-bleeding risk patients undergoing percutaneous coronary intervention (PCI) with DCB. The study will involve multiple centers and will include a one-year clinical follow-up with assessments at 30 days, 6 months, and 12 months. The angiographic outcomes will be analyzed in a core lab that is blinded to procedural results.

Who should consider this trial

Good fit: Ideal candidates include patients with small native coronary arteries requiring PCI and those with high-bleeding risk factors.

Not a fit: Patients with larger coronary lesions or those not requiring PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer treatment option for patients with small coronary arteries who are at high risk of bleeding.

How similar studies have performed: Previous studies have shown promise with drug-coated balloon therapies, but this specific approach in high-bleeding risk patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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.
* If the patient has a high-bleeding risk defined by 1) PRECISE-DAPT SCORE ≥ 25 or 2) an indication for concomitant oral anticoagulation he can be included in the high- bleeding risk substudy as long as he does not meet the specific exclusion criteria.

Exclusion Criteria:

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.
* Specific exclusion criteria for the high-bleeding risk patient subgroup:
* Past medical history of stent thrombosis.
* Indication for dual antiplatelet therapy for a different reason.

Where this trial is running

Naples and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery Diseasedrug-coated balloonpaclitaxelsmall native vessel coronary artery diseasecoronary stenoses
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.