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

Medical University of Graz

Status: Unknown

Conditions: Obstructive Coronary Artery Disease

Treatments: Device: FFR-guided coronary revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT03712644

30-194 ex 17/18

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Conservative

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Device: FFR-guided coronary revascularization