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

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ClinicalTrials.gov Identifier: NCT03712644
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gabor Toth-Gayor, Medical University of Graz

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.


Condition or disease Intervention/treatment Phase
Obstructive Coronary Artery Disease Device: FFR-guided coronary revascularization Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
Actual Study Start Date : July 11, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


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.

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.




Primary Outcome Measures :
  1. Rate of composite of overall death and spontaneous myocardial infarction [ Time Frame: 1-year ]

Secondary Outcome Measures :
  1. Rate of composite of overall death and spontaneous myocardial infarction [ Time Frame: 2-years ]
  2. Rate of overall death [ Time Frame: 1- and 2-years ]
  3. Rate of spontaneous myocardial infarction [ Time Frame: 1- and 2-years ]
  4. Quality of life (EQ5D) development [ Time Frame: 1- and 2-years ]
  5. Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke [ Time Frame: 1- and 2-years ]
  6. Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization [ Time Frame: 1- and 2-years ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712644


Contacts
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Contact: Gabor G Toth, MD, PhD 004331638512544 gabor.g.toth@medunigraz.at
Contact: Nicole Peischl, BA 004331638581367 Nicole.Peischl@klinikum-graz.at

Locations
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Austria
Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz Recruiting
Graz, Austria, 8036
Contact: Gabor G Toth, MD, PhD    0043 316385 12 544    gabor.g.toth@medunigraz.at   
Sub-Investigator: Marianne Brodmann, MD, PhD         
Hungary
Bacs-Kiskun County Hospital Recruiting
Kecskemet, Hungary, 6000
Contact: Zoltan Ruzsa, MD, PhD       zruzsa25@gmail.com   
Sponsors and Collaborators
Medical University of Graz
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gabor Toth-Gayor, Staff-member interventional cardiologist, Medical University of Graz
ClinicalTrials.gov Identifier: NCT03712644     History of Changes
Other Study ID Numbers: 30-194 ex 17/18
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabor Toth-Gayor, Medical University of Graz:
Critical limb ischemia
Coronary artery disease
Fractional flow reserve-guided coronary revascularization

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes