Feasibility and Outcomes of Complete Coronary Revascularization Using Bioresorbable Vascular Scaffold in All-comer Patients With Stable and Unstable Angina: A Multi-centre Registry in Russian Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,602
- 试验地点
- 12
- 主要终点
- Any revascularization
研究概览
简要总结
The aim of the study is feasibility of complete coronary revascularization with bioresorbable vascular scaffold (BVS) implantation and assessment of treatment outcomes in a group of consecutive patients with stable and unstable angina in Russian population.
The hypothesis of this registry study: 1) Complete coronary revascularization with BVS implantation will be feasible to perform in at least 70 percent of patient population with stable and unstable angina qualified for revascularization after coronary angiography, 2) Complete revascularization with BVS is as safe and effective as revascularization with standard BMS (Bare Metal Stent BMS/ Drug Eluting Stent DES stent implantation (published literature comparators in matched populations).
Up to 2500 patients will be enrolled in 13 Russian high volume invasive cardiology centres. 12 month clinical observation and 5-year clinical follow-up is expected.
详细描述
Study design: Data regarding all consecutive patients qualified for revascularization (PCI Percutaneous Coronary Intervention or CABG Coronary Artery Bypass Grafting) will be collected in this prospective study. Information regarding revascularization strategy will be collected as detailed information concerning PCI procedure. In case of PCI with other than BVS stent implantation (BMS or/and metallic DES) information collected in the study will contain at least:
- Reason why BVS was not implanted
- Final result of baseline treatment
- Acute and long-term outcome of treatment (12 month clinical observation); NB. 5-year clinical follow-up is also expected.
The enrollment phase of the registry is not expected to last longer than 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient characteristics
- •Age > 18 years
- •Able and willing to give informed consent
- •Willing to comply with specified follow-up evaluations
- •Clinical manifestation of coronary artery disease: stable angina or unstable angina
- •Indications for coronary revascularization
排除标准
- •Patient characteristics
- •Acute Myocardial infarction
- •Cardiogenic shock
- •Any reason for patient's inability to comply with 12-month double antiplatelet therapy (DAPT)
- •Absolute contraindications to DES or BVS implantation
结局指标
主要结局
Any revascularization
时间窗: in 12 month follow-up
Numbers of any revascularization per patient.
Angiographic endpoints: assessment of stent implantation final result: percentage of residual stenosis (%)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result: dissection (yes/no)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result: no-flow (yes/no)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result: coronary artery perforation (yes/no)
时间窗: periprocedural
Periprocedural MI (Myocardial Infarction) (yes/no)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result:stent delivery, technical success (yes/no)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result: side-branch occlusion (yes/no)
时间窗: periprocedural
Acute gain (mm)
时间窗: periprocedural
Angiographic endpoints: assessment of stent implantation final result: slow-flow (yes/no)
时间窗: periprocedural
Major Adverse Cardiovascular Events
时间窗: in 12 month follow up
Angina assessment questionnaire
时间窗: 12 month follow-up
Angiographic endpoints: assessment of stent implantation final result: distal embolization (yes/no)
时间窗: periprocedural
TVF (Target Vessel Failure)
时间窗: in 12 month follow-up
Stent thrombosis (possible and probable)
时间窗: in 12 month follow-up
次要结局
未报告次要终点