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

NCT06321757 | Recruiting DMC

• 1 other identifier: EPIC30-PARIS
• Study Type: observational
• Target: 501
• Locations: 3 countries
• Sites: 18

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

drug-coated balloon; paclitaxel; small native vessel coronary artery disease; coronary stenoses

Outcome Measures

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

  1 year

Secondary Outcomes (8)

• Cardiac death

  1 year

• All-cause mortality

  1 year

• Target vessel myocardial infarction

  1 year

• New target lesion revascularization (TLR)

  1 year

• Target vessel failure (TVF)

  1 year

Study Arms (1)

Patients with small native vessel coronary artery disease

\- Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk

Device: Percutaneous Coronary Intervention with DCB and DAPT

Interventions

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

Patients with small native vessel coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Past medical history of stent thrombosis.
• Indication for dual antiplatelet therapy for a different reason.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (18)

Clinica Mediterranea

Naples, 08122, Italy

RECRUITING

Ulslo-H.Santa Cruz

Carnaxide, Portugal

RECRUITING

ULS Santa Maria

Lisbon, Portugal

RECRUITING

Hospital General Universitario de Albacete

Albacete, 02008, Spain

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

RECRUITING

Hospital Universitario de Cruces

Barakaldo, 49803, Spain

RECRUITING

University Hospital HM Montepríncipe

Boadilla del Monte, 28660, Spain

RECRUITING

Hospital General Universitario de Ciudad Real

Ciudad Real, 13005, Spain

RECRUITING

Hospital Universitario Clinico San Cecilio

Granada, 18016, Spain

RECRUITING

Hospital Universitario Juan Ramon Jimenez

Huelva, 21005, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

RECRUITING

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35010, Spain

RECRUITING

Hospital Universitario de Leon

León, 24071, Spain

RECRUITING

Hospital Universitario de La Princesa

Madrid, 28006, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Hospital Universitario Y Politecnico La Fe

Valencia, 46026, Spain

RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 74678 BACKGROUND

• 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.

  PMID: 2950322 BACKGROUND

• 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.

  PMID: 12050336 BACKGROUND

• 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.

  PMID: 19528338 BACKGROUND

• 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.

  PMID: 25349065 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

IGNACIO J AMAT SANTOS, MD, PhD

CONTACT

34983420000; ijamat@gmail.com

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 20, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

PT (2); ES (15); IT (1)