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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
650
Stenoses in range of 50-90% diameter stenosis in major coronary arteries will be assessed by FFR, and revascularized if FFR equal to or lower than 0.80. Lesions above 90% diameter stenosis in will be revascularized without further assessment.
Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
Graz, Austria
RECRUITINGBacs-Kiskun County Hospital
Kecskemét, Hungary
RECRUITINGRate of composite of overall death and spontaneous myocardial infarction
Time frame: 1-year
Rate of composite of overall death and spontaneous myocardial infarction
Time frame: 2-years
Rate of overall death
Time frame: 1- and 2-years
Rate of spontaneous myocardial infarction
Time frame: 1- and 2-years
Quality of life (EQ5D) development
Time frame: 1- and 2-years
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
Time frame: 1- and 2-years
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization
Time frame: 1- and 2-years
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