Clinical trial NCT03712644: Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia
Official title: Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Coronary Artery Disease
Keywords: Critical limb ischemia
Coronary artery disease
Fractional flow reserve-guided coronary revascularization
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of composite of overall death and spontaneous myocardial infarction
timeFrame: 1-year
Secondary outcomes:
measure: Rate of composite of overall death and spontaneous myocardial infarction
timeFrame: 2-years
measure: Rate of overall death
timeFrame: 1- and 2-years
measure: Rate of spontaneous myocardial infarction
timeFrame: 1- and 2-years
measure: Quality of life (EQ5D) development
timeFrame: 1- and 2-years
measure: Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
timeFrame: 1- and 2-years
measure: Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization
timeFrame: 1- and 2-years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun County Hospital
Study officials:
affiliation: Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria
name: Gabor G Toth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bacs-Kiskun County Hospital, Kecskemet, Hungary
name: Zoltan Ruzsa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria
name: Marianne Brodmann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toth G, Brodmann M, Barbato E, Mangiacapra F, Schneller L, Orias V, Gil R, Bil J, Bartus S, Ruzsa Z. Rational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial). Am Heart J. 2019 Aug;214:107-112. doi: 10.1016/j.ahj.2019.05.005. Epub 2019 May 16.