PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 501
- 试验地点
- 34
- 主要终点
- Effectiveness of DCB therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Patients with small native vessel coronary artery disease
- Patients with small native vessel coronary artery disease y/or patients with High Bleeding Risk
干预措施: Percutaneous Coronary Intervention with DCB and DAPT (Device)
结局指标
主要结局
Effectiveness of DCB therapy
时间窗: 1 year
Incidence of MACE, which is a composite endpoint including cardiac mortality, myocardial infarction, and new revascularization of the target lesion
次要结局
- All-cause mortality(1 year)
- Target vessel failure (TVF)(1 year)
- Major bleeding(1 year)
- Cardiac death(1 year)
- Target vessel myocardial infarction(1 year)
- New target lesion revascularization (TLR)(1 year)
- Minor bleeding(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)(1 year)