- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712644
Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia (INCORPORATE)
Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gabor G Toth, MD, PhD
- Phone Number: 004331638512544
- Email: gabor.g.toth@medunigraz.at
Study Contact Backup
- Name: Nicole Peischl, BA
- Phone Number: 004331638581367
- Email: Nicole.Peischl@klinikum-graz.at
Study Locations
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-
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Graz, Austria, 8036
- Recruiting
- Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
-
Contact:
- Gabor G Toth, MD, PhD
- Phone Number: 0043 316385 12 544
- Email: gabor.g.toth@medunigraz.at
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Sub-Investigator:
- Marianne Brodmann, MD, PhD
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-
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Kecskemet, Hungary, 6000
- Recruiting
- Bacs-Kiskun County Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Conservative
Patients will receive primarily optimal medical therapy alone and followed, according to protocol.
Any further cardiologic investigation will be performed only in case of clinical suspicion of myocardial ischemia related symptoms.
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EXPERIMENTAL: Invasive
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of composite of overall death and spontaneous myocardial infarction
Time Frame: 1-year
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1-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of composite of overall death and spontaneous myocardial infarction
Time Frame: 2-years
|
2-years
|
Rate of overall death
Time Frame: 1- and 2-years
|
1- and 2-years
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Rate of spontaneous myocardial infarction
Time Frame: 1- and 2-years
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1- and 2-years
|
Quality of life (EQ5D) development
Time Frame: 1- and 2-years
|
1- and 2-years
|
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
Time Frame: 1- and 2-years
|
1- and 2-years
|
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization
Time Frame: 1- and 2-years
|
1- and 2-years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabor G Toth, MD, PhD, Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria
- Principal Investigator: Zoltan Ruzsa, MD, PhD, Bacs-Kiskun County Hospital, Kecskemet, Hungary
- Principal Investigator: Marianne Brodmann, MD, PhD, Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30-194 ex 17/18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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