Obstructive Coronary Artery Disease
Conditions
Keywords
Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization
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.
Interventions
DEVICEFFR-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.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of composite of overall death and spontaneous myocardial infarction | 1-year |
Secondary
| Measure | Time frame |
|---|---|
| Rate of overall death | 1- and 2-years |
| Rate of spontaneous myocardial infarction | 1- and 2-years |
| Rate of composite of overall death and spontaneous myocardial infarction | 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 |
| Quality of life (EQ5D) development | 1- and 2-years |
Countries
Austria, Hungary
Contacts
Primary ContactGabor G Toth, MD, PhD
Backup ContactNicole Peischl, BA
Outcome results
None listed