Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia (INCORPORATE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03712644|
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : November 6, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.|
|Masking:||None (Open Label)|
|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|
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.
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.
- Rate of composite of overall death and spontaneous myocardial infarction [ Time Frame: 1-year ]
- Rate of composite of overall death and spontaneous myocardial infarction [ Time Frame: 2-years ]
- Rate of overall death [ Time Frame: 1- and 2-years ]
- Rate of spontaneous myocardial infarction [ Time Frame: 1- and 2-years ]
- Quality of life (EQ5D) development [ Time Frame: 1- and 2-years ]
- Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke [ Time Frame: 1- and 2-years ]
- Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization [ Time Frame: 1- and 2-years ]
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
|Contact: Gabor G Toth, MD, PhDfirstname.lastname@example.org|
|Contact: Nicole Peischl, BA||004331638581367||Nicole.Peischl@klinikum-graz.at|
|Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz||Recruiting|
|Graz, Austria, 8036|
|Contact: Gabor G Toth, MD, PhD 0043 316385 12 544 email@example.com|
|Sub-Investigator: Marianne Brodmann, MD, PhD|
|Bacs-Kiskun County Hospital||Recruiting|
|Kecskemet, Hungary, 6000|
|Contact: Zoltan Ruzsa, MD, PhD firstname.lastname@example.org|
|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|