NCT03712644

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Medical University of Graz · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	FFR-guided coronary revascularization	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.

Timeline

• Start date: 2018-07-11
• Primary completion: 2021-08-31
• Completion: 2022-08-31
• First posted: 2018-10-19
• Last updated: 2018-11-06

Locations

2 sites across 2 countries: Austria, Hungary