PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
NCT ID: NCT06321757
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
501 participants
OBSERVATIONAL
2024-02-26
2026-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
As per clinical practice, 1-year clinical follow-up of all the patients will be conducted with a first assessment at 30 days, a second assessment at 6 months, and one final assessment at 12 months.
Should the patient have an elevated bleeding risk -defined as concomitant therapy with oral anticoagulation or a PRECISE-DAPT score ≥ 25- patients will be included in a high-bleeding risk substudy. The antiplatelet therapy regime will be administered according to the local investigator and the treating medical team.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with small native vessel coronary artery disease
\- Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk
Percutaneous Coronary Intervention with DCB and DAPT
* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT)
* Patients with PCI (DCB) + short DAPT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous Coronary Intervention with DCB and DAPT
* Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT)
* Patients with PCI (DCB) + short DAPT
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Past medical history of stent thrombosis.
* Indication for dual antiplatelet therapy for a different reason.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación EPIC
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ulslo-H.Santa Cruz
Carnaxide, , Portugal
ULS Santa Maria
Lisbon, , Portugal
Hospital General Universitario de Albacete
Albacete, , Spain
Hospital General Universitario Dr. Balmis
Alicante, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
University Hospital HM Montepríncipe
Boadilla del Monte, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Clinico San Cecilio
Granada, , Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital Universitario de Leon
León, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.
Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
Kirtane AJ, Gupta A, Iyengar S, Moses JW, Leon MB, Applegate R, Brodie B, Hannan E, Harjai K, Jensen LO, Park SJ, Perry R, Racz M, Saia F, Tu JV, Waksman R, Lansky AJ, Mehran R, Stone GW. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009 Jun 30;119(25):3198-206. doi: 10.1161/CIRCULATIONAHA.108.826479. Epub 2009 Jun 15.
Kleber FX, Schulz A, Waliszewski M, Hauschild T, Bohm M, Dietz U, Cremers B, Scheller B, Clever YP. Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty. Clin Res Cardiol. 2015 Mar;104(3):217-25. doi: 10.1007/s00392-014-0775-2. Epub 2014 Oct 28.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EPIC30-PARIS
Identifier Type: -
Identifier Source: org_study_id