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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention with DCB and DAPT

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 501

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: IGNACIO J AMAT SANTOS, MD, PhD; Phone Number: 86571 34983420000; Email: ijamat@gmail.com

Study Locations

• Italy
  • Naples, Italy, 08122
    • Recruiting
    • Clinica Mediterranea
• Portugal
  • Carnaxide, Portugal
    • Recruiting
    • Ulslo-H.Santa Cruz
  • Lisbon, Portugal
    • Recruiting
    • ULS Santa Maria
• Spain
  • Albacete, Spain, 02008
    • Recruiting
    • Hospital General Universitario de Albacete
  • Alicante, Spain, 03010
    • Recruiting
    • Hospital General Universitario Dr. Balmis
  • Barakaldo, Spain, 49803
    • Recruiting
    • Hospital Universitario de Cruces
  • Boadilla del Monte, Spain, 28660
    • Recruiting
    • University Hospital HM Montepríncipe
  • Ciudad Real, Spain, 13005
    • Recruiting
    • Hospital General Universitario de Ciudad Real
  • Granada, Spain, 18016
    • Recruiting
    • Hospital Universitario Clínico San Cecilio
  • Huelva, Spain, 21005
    • Recruiting
    • Hospital Universitario Juan Ramon Jimenez
  • L'Hospitalet de Llobregat, Spain, 08907
    • Recruiting
    • Hospital Universitari de Bellvitge
  • Las Palmas de Gran Canaria, Spain, 35010
    • Recruiting
    • Hospital Universitario de Gran Canaria Doctor Negrin
  • León, Spain, 24071
    • Recruiting
    • Hospital Universitario de Leon
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Universitario de la Princesa
  • San Cristóbal de La Laguna, Spain
    • Recruiting
    • Hospital Universitario de Canarias
  • Seville, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen Del Rocio
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politécnico La Fe
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Patients with PCI (DCB) + standard DAPT standard dual antiplatelet therapy (DAPT); Patients with PCI (DCB) + short DAPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Incidence of Cardiac death	1 year
All-cause mortality	Incidence of All-cause mortality	1 year
Target vessel myocardial infarction	Incidence of Target vessel myocardial infarction	1 year
New target lesion revascularization (TLR)	Incidence of New target lesion revascularization (TLR)	1 year
Target vessel failure (TVF)	Incidence of Target vessel failure (TVF)	1 year
Major bleeding	Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5	1 year
Minor bleeding	Anemia, defined as Hb<12g/dL for women and <13g/dL for men	1 year
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

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: paclitaxel; drug-coated balloon; coronary stenoses; small native vessel coronary artery disease
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: EPIC30-PARIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No