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

Launched by FUNDACIÓN EPIC · Mar 14, 2024

Keywords

ClinConnect Summary

The PREVAIL trial is studying a specific treatment called a drug-coated balloon (DCB) for patients with coronary artery disease, particularly those with small blood vessels and a higher risk of bleeding. The goal is to see how effective this treatment is in real-life situations and to assess how safe it is to use a shorter period of blood-thinning medication (only 7 days) for these patients. This trial is currently looking for participants who are between 65 and 74 years old and have certain conditions like narrow blood vessels less than 3 mm wide, or have had heart issues that require treatment.

To be eligible for the trial, patients should have a specific medical need for the DCB treatment and should be able to understand and sign a consent form. They should also have a higher risk of bleeding due to their medical history, but there are some criteria that would disqualify them, such as having larger blood vessel issues or a life expectancy of less than a year. Participants can expect to undergo a procedure using the DCB, and their outcomes will be monitored closely. This trial is important for understanding how this treatment can help patients with challenging conditions while managing their bleeding risks effectively.

Gender

ALL

Eligibility 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.