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

NCT03712644 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2018-11-06

No results posted yet for this study

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.

Conditions

  • Obstructive Coronary Artery Disease

Interventions

DEVICE

FFR-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 & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Gabor G Toth, MD, PhD · Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria

  • Zoltan Ruzsa, MD, PhD · Bacs-Kiskun County Hospital, Kecskemet, Hungary

  • Marianne Brodmann, MD, PhD · Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-11
Primary Completion
2021-08-31
Completion
2022-08-31

Countries

  • Austria
  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712644 on ClinicalTrials.gov