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

NCT03712644 | Unknown DMC

• 1 other identifier: 30-194 ex 17/18
• Study Type: interventional
• Target: 650
• Locations: 2 countries
• Sites: 2

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

Keywords

Critical limb ischemia; Coronary artery disease; Fractional flow reserve-guided coronary revascularization

Outcome Measures

Primary Outcomes (1)

• Rate of composite of overall death and spontaneous myocardial infarction

  1-year

Secondary Outcomes (6)

• Rate of composite of overall death and spontaneous myocardial infarction

  2-years

• Rate of overall death

  1- and 2-years

• Rate of spontaneous myocardial infarction

  1- and 2-years

• Quality of life (EQ5D) development

  1- and 2-years

• Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke

  1- and 2-years

Study Arms (2)

Conservative

NO INTERVENTION

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.

Invasive

EXPERIMENTAL

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

Interventions

FFR-guided coronary revascularization 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.

Invasive

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

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

Graz, 8036, Austria

RECRUITING

Bacs-Kiskun County Hospital

Kecskemét, 6000, Hungary

RECRUITING

Related Publications (2)

• 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.

  PMID: 38990250 DERIVED

• 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.

  PMID: 31200280 DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabor G Toth, MD, PhD

CONTACT

004331638512544; gabor.g.toth@medunigraz.at

Nicole Peischl, BA

CONTACT

004331638581367; Nicole.Peischl@klinikum-graz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff-member interventional cardiologist

Model Details: non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: July 11, 2018
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2022
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

AU (1); HU (1)