Coronary Artery Disease Clinical Trial
— PARISOfficial title:
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Fundación EPIC |
Spain,
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
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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 |
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