Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 376
- 试验地点
- 10
- 主要终点
- Composite endpoint of major adverse cardiac event (MACE)
研究概览
简要总结
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 ischemic symptoms and/or evidence of myocardial ischemia
- •Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
- •Availability of an OCT-pullback of the target lesion
- •Written informed consent by the patient for participation in the study.
- •Age ≥ 18 years
排除标准
- •Cardiogenic shock
- •Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
- •Target lesion located in left main trunk or bypass graft.
- •Additional coronary intervention planned within 30 days of the procedure.
- •Non-successful treatment of other lesion(s) during the same procedure
- •Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
- •Contraindications to any components of the investigational devices or dual antiplatelet therapy
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial or participation in any other study at the time of enrollment.
- •Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
- •Patient's inability to fully comply with the study protocol
研究组 & 干预措施
homogenous
Stratification - homogenous pattern
干预措施: Drug eluting stent (DES) (Device)
homogenous
Stratification - homogenous pattern
干预措施: Drug coated ballloon (DCB) (Device)
heterogenous
Stratification - homogenous pattern
干预措施: Drug eluting stent (DES) (Device)
heterogenous
Stratification - homogenous pattern
干预措施: Drug coated ballloon (DCB) (Device)
结局指标
主要结局
Composite endpoint of major adverse cardiac event (MACE)
时间窗: 24 months of clinical follow-up after randomization
Composite endpoint of major adverse cardiac event (MACE) * all-cause death * myocardial infarction * target lesion revascularization (TLR)
次要结局
- Individual endpoints of the composite endpoints(24 months of clinical follow-up after randomization)
- Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR(24 months of clinical follow-up after randomization)
- Stent thrombosis according to the ARC criteria(24 months of clinical follow-up after randomization)
- Safety endpoint: a composite endpoint of all-cause death and myocardial infarction(24 months of clinical follow-up after randomization)