PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Percutaneous Coronary Intervention with DCB and DAPT
- Registration Number
- NCT06321757
- Lead Sponsor
- Fundación EPIC
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 501
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.
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with small native vessel coronary artery disease Percutaneous Coronary Intervention with DCB and DAPT - Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk
- Primary Outcome Measures
Name Time Method Effectiveness of DCB therapy 1 year Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion
- Secondary Outcome Measures
Name Time Method All-cause mortality 1 year Incidence of All-cause mortality
Target vessel failure (TVF) 1 year Incidence of Target vessel failure (TVF)
Major bleeding 1 year Bleeding defined as BARC (Bleeding Academic Research Consortium) criteria 2,3 or 5
Cardiac death 1 year Incidence of Cardiac death
Target vessel myocardial infarction 1 year Incidence of Target vessel myocardial infarction
New target lesion revascularization (TLR) 1 year Incidence of New target lesion revascularization (TLR)
Minor bleeding 1 year Anemia, defined as Hb\<12g/dL for women and \<13g/dL for men
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) 1 year safety analysis of short DAP (dual antiplatelet therapy) in terms of thrombotic risk after PCI
Trial Locations
- Locations (15)
Hospital Universitario de Canarias
🇪🇸La Laguna, Spain
ULS Santa Maria
🇵🇹Lisboa, Portugal
Hospital General Universitario de Albacete
🇪🇸Albacete, Spain
Hospital General Universitario Dr. Balmis
🇪🇸Alicante, Spain
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital General Universitario de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital Universitario Clinico San Cecilio
🇪🇸Granada, Spain
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de Llobregat, Spain
Hospital Universitario Juan Ramon Jimenez
🇪🇸Huelva, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
🇪🇸Las Palmas De Gran Canaria, Spain
Hospital Universitario de Leon
🇪🇸León, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitario Y Politecnico La Fe
🇪🇸Valencia, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain