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

Not Applicable

• Conditions: Obstructive Coronary Artery Disease
• Interventions: Device: FFR-guided coronary revascularization

• Registration Number: NCT03712644
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-11
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-03
• Last Update Posted: 2018-11-06
• Primary Completion: 2021-08-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive	FFR-guided coronary revascularization	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.

Primary Outcome Measures

Name	Time	Method
Rate of composite of overall death and spontaneous myocardial infarction	1-year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz; 🇦🇹 Graz, Austria

Bacs-Kiskun County Hospital; 🇭🇺 Kecskemet, Hungary