Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia

Study Overview
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Brief Summary
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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.

Official Title
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Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia

Conditions
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Obstructive Coronary Artery Disease

Intervention / Treatment
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* Device: FFR-guided coronary revascularization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative<br>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. | |
| Experimental: Invasive<br>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. | Device: FFR-guided coronary revascularization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of composite of overall death and spontaneous myocardial infarction |  | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of composite of overall death and spontaneous myocardial infarction |  | 2-years | 
| Rate of overall death |  | 1- and 2-years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization