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

Coronary Artery Disease Clinical Trial

— PARIS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321757
• Other study ID #: EPIC30-PARIS
• Status: Recruiting
• Start date: February 26, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: May 2024
• Source: Fundación EPIC
• Contact: IGNACIO J AMAT SANTOS, MD, PhD
• Phone: 34983420000
• Email: ijamat[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Post-market, prospective, multicenter, non-intervention study, to demonstrate the effectiveness of drug-coated ballon 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 PCI with DCB will be performed in patients with native vessel coronary artery disease based on the criterion of the treating physician. The angiographic study will be analyzed in a core lab (icicorelab) blinded to the procedural outcomes and the patients' follow-up.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 501
• Est. completion date: December 30, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with:

• PCI with DCB on native arteries with diameters < 3 mm.

• Indication for PCI on non-culprit lesions 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.

• 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.

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Percutaneous Coronary Intervention with DCB and DAPT
Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT) Patients with PCI (DCB) + short DAPT

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Albacete	Albacete
Spain	Hospital Universitario Clinico San Cecilio	Granada
Spain	Hospital Universitario Juan Ramon Jimenez	Huelva
Spain	Hospital Universitario de Leon	León
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Y Politecnico La Fe	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac death	Incidence of Cardiac death	1 year
Secondary	All-cause mortality	Incidence of All-cause mortality	1 year
Secondary	Target vessel myocardial infarction	Incidence of Target vessel myocardial infarction	1 year
Secondary	New target lesion revascularization (TLR)	Incidence of New target lesion revascularization (TLR)	1 year
Secondary	Target vessel failure (TVF)	Incidence of Target vessel failure (TVF)	1 year
Secondary	Major bleeding	Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5	1 year
Secondary	Minor bleeding	Anemia, defined as Hb<12g/dL for women and <13g/dL for men	1 year
Secondary	1-year MACE indicende (cardiac mortality, myocardial infarction, and new revascularization of the target lesion) in high-bleeding risk patients treated with a short dual antiplatelet treatment (7 days)	safety analysis of short DAP (dual antiplatelet therapy) in terms of thrombotic risk after PCI	1 year