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

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    650
  • sponsor
    Medical University of Graz
Updated on 15 February 2022

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.

Details
Condition Obstructive Coronary Artery Disease
Treatment FFR-guided coronary revascularization
Clinical Study IdentifierNCT03712644
SponsorMedical University of Graz
Last Modified on15 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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