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

NCT ID: NCT03712644

Last Updated: 2018-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2022-08-31

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.

Conditions

Obstructive Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

FFR-guided coronary revascularization

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Gabor Toth-Gayor

Staff-member interventional cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gabor G Toth, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria

Zoltan Ruzsa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Bacs-Kiskun County Hospital, Kecskemet, Hungary

Marianne Brodmann, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria

Locations

Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz

Graz, , Austria

Site Status: RECRUITING

Bacs-Kiskun County Hospital

Kecskemét, , Hungary

Site Status: RECRUITING

Countries

Austria; Hungary

Central Contacts

Gabor G Toth, MD, PhD

Role: CONTACT

gabor.g.toth@medunigraz.at

004331638512544

Nicole Peischl, BA

Role: CONTACT

Nicole.Peischl@klinikum-graz.at

004331638581367

Facility Contacts

Gabor G Toth, MD, PhD

Role: primary

gabor.g.toth@medunigraz.at

0043 316385 12 544

Zoltan Ruzsa, MD, PhD

Role: primary

zruzsa25@gmail.com

References

Toth GG, Brodmann M, Kanoun Schnur SS, Bartus S, Vrsalovic M, Krestianinov O, Kala P, Bil J, Gil R, Kanovsky J, Di Serafino L, Paolucci L, Barbato E, Mangiacapra F, Ruzsa Z. Intentional coronary revascularization versus conservative therapy in patients after peripheral artery revascularization due to critical limb ischemia: the INCORPORATE trial. Clin Res Cardiol. 2025 Aug;114(8):991-999. doi: 10.1007/s00392-024-02487-2. Epub 2024 Jul 11.

Reference Type: DERIVED

PMID: 38990250 (View on PubMed)

Toth G, Brodmann M, Barbato E, Mangiacapra F, Schneller L, Orias V, Gil R, Bil J, Bartus S, Ruzsa Z. Rational and design of the INtentional COronary revascularization versus conservative therapy in patients undergOing successful peripheRAl arTEry revascularization due to critical limb ischemia trial (INCORPORATE trial). Am Heart J. 2019 Aug;214:107-112. doi: 10.1016/j.ahj.2019.05.005. Epub 2019 May 16.

Reference Type: DERIVED

PMID: 31200280 (View on PubMed)

Other Identifiers

30-194 ex 17/18

Identifier Type: -

Identifier Source: org_study_id