Clinical trial NCT06321757: PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Official title: PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: drug-coated balloon
paclitaxel
small native vessel coronary artery disease
coronary stenoses
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: drug-coated ballon therapy in real-world patients with small native vessel coronary artery disease

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.

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.

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.

Primary outcomes:
measure: Effectiveness of DCB therapy
timeFrame: 1 year
Secondary outcomes:
measure: Cardiac death
timeFrame: 1 year
measure: All-cause mortality
timeFrame: 1 year
measure: Target vessel myocardial infarction
timeFrame: 1 year
measure: New target lesion revascularization (TLR)
timeFrame: 1 year
measure: Target vessel failure (TVF)
timeFrame: 1 year
measure: Major bleeding
timeFrame: 1 year
measure: Minor bleeding
timeFrame: 1 year
measure: 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)
timeFrame: 1 year
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: ULS Santa Maria
city: Albacete
country: Spain
facility: Hospital General Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario Dr. Balmis
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Granada
country: Spain
facility: Hospital Universitario Clinico San Cecilio
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: León
country: Spain
facility: Hospital Universitario de Leon
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario Y Politecnico La Fe
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
Study officials:
References:
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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.
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.
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.