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

Obstructive Coronary Artery Disease Clinical Trial

— INCORPORATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03712644
• Other study ID #: 30-194 ex 17/18
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2018
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2018
• Source: Medical University of Graz
• Contact: Gabor G Toth, MD, PhD
• Phone: 004331638512544
• Email: gabor.g.toth[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Ischemia
• Myocardial Ischemia
• Obstructive Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Austria	Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz	Graz
Hungary	Bacs-Kiskun County Hospital	Kecskemet

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Countries where clinical trial is conducted

Austria,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of composite of overall death and spontaneous myocardial infarction		1-year
Secondary	Rate of composite of overall death and spontaneous myocardial infarction		2-years
Secondary	Rate of overall death		1- and 2-years
Secondary	Rate of spontaneous myocardial infarction		1- and 2-years
Secondary	Quality of life (EQ5D) development		1- and 2-years
Secondary	Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke		1- and 2-years
Secondary	Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization		1- and 2-years