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

November 3, 2018 updated by: Gabor Toth-Gayor, Medical University of Graz

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

Study Type

Interventional

Enrollment (Anticipated)

650

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Graz, Austria, 8036
        • Recruiting
        • Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
        • Contact:
        • Sub-Investigator:
          • Marianne Brodmann, MD, PhD
      • Kecskemet, Hungary, 6000
        • Recruiting
        • Bacs-Kiskun County Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

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
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
Rate of spontaneous myocardial infarction
Time Frame: 1- and 2-years
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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 11, 2018

Primary Completion (ANTICIPATED)

August 31, 2021

Study Completion (ANTICIPATED)

August 31, 2022

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (ACTUAL)

October 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2018

Last Update Submitted That Met QC Criteria

November 3, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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