Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 650
- 试验地点
- 4
- 主要终点
- Rate of composite of overall death and spontaneous myocardial infarction
研究概览
简要总结
The objective of the INCORPORATE trial is to evaluate whether an intentional invasive strategy with ischemia targeted, reasonably complete coronary revascularization and optimal medical therapy is superior as compared to a primary conservative approach and optimal medical therapy alone in terms of spontaneous myocardial infarct-free and overall survival in patients with severe peripheral artery disease, underwent peripheral artery revascularization due to critical limb ischemia.
The INCORPORATE trial is designed to be non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, undergoing successful peripheral revascularization (percutaneous or surgical) due to critical limb ischemia will be screened, and enrolled if informed consent form is signed and none of the following
排除标准
- •Exclusion Criteria:
- •contraindication for double antiplatelet therapy for at least one month;
- •contraindication for guideline-conform longterm antiplatelet/anticoagulation regime after PCI;
- •heart failure with ejection fraction below 35%;
- •significant valvular heart disease with indication for surgical or percutaneous repair;
- •any concomitant disease with a life expectancy less than 2 years;
- •severe renal dysfunction with glomerular filtration rate below 30 mL/min/1.73m2;
- •ongoing sepsis.
- •Patients, who cannot be enrolled for any reasons will enter a prospective registry.
研究组 & 干预措施
Conservative
Patients will receive primarily optimal medical therapy alone and followed, according to protocol. Any further cardiologic investigation will be performed only in case of clinical suspicion of myocardial ischemia related symptoms.
Invasive
In the Invasive group in addition to optimal medical therapy elective coronary angiography will be performed. Coronary catheterization is preferably scheduled within a maximum of 14 days after peripheral revascularization
All lesions of 50-90% diameter stenosis in a major coronary artery will be evaluated by fractional flow reserve (FFR) and intervened by percutaneous coronary intervention (PCI) if FFR≤0.80 or left for medical therapy if FFR>0.80. All lesions of ≥90% diameter stenosis in a major coronary artery will be intervened. This includes also efforts to recanalize chronic total occlusions (CTO) of large supplied viable myocardial territory.
For complex cases revascularization by coronary artery bypass surgery might be considered, however PCI is preferred whenever possible.
干预措施: FFR-guided coronary revascularization (Device)
结局指标
主要结局
Rate of composite of overall death and spontaneous myocardial infarction
时间窗: 1-year
次要结局
- Rate of spontaneous myocardial infarction(1- and 2-years)
- Quality of life (EQ5D) development(1- and 2-years)
- Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke(1- and 2-years)
- Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization(1- and 2-years)
- Rate of composite of overall death and spontaneous myocardial infarction(2-years)
- Rate of overall death(1- and 2-years)
研究者
Gabor Toth-Gayor
Staff-member interventional cardiologist
Medical University of Graz