Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia (INCORPORATE)
Obstructive Coronary Artery Disease
About this trial
This is an interventional treatment trial for Obstructive Coronary Artery Disease focused on measuring Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization
Eligibility Criteria
Inclusion Criteria:
- 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 exclusion criteria is met.
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.
Sites / Locations
- Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University GrazRecruiting
- Bacs-Kiskun County HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Conservative
Invasive
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.
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.