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

Primary Purpose

Obstructive Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
FFR-guided coronary revascularization
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Coronary Artery Disease focused on measuring Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University GrazRecruiting
  • Bacs-Kiskun County HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conservative

Invasive

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of composite of overall death and spontaneous myocardial infarction

Secondary Outcome Measures

Rate of composite of overall death and spontaneous myocardial infarction
Rate of overall death
Rate of spontaneous myocardial infarction
Quality of life (EQ5D) development
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization

Full Information

First Posted
October 17, 2018
Last Updated
November 3, 2018
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT03712644
Brief Title
Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia
Acronym
INCORPORATE
Official Title
Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2018 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Coronary Artery Disease
Keywords
Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative
Arm Type
No Intervention
Arm Description
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.
Arm Title
Invasive
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
FFR-guided coronary revascularization
Intervention Description
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 Measure Information:
Title
Rate of composite of overall death and spontaneous myocardial infarction
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Rate of composite of overall death and spontaneous myocardial infarction
Time Frame
2-years
Title
Rate of overall death
Time Frame
1- and 2-years
Title
Rate of spontaneous myocardial infarction
Time Frame
1- and 2-years
Title
Quality of life (EQ5D) development
Time Frame
1- and 2-years
Title
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
Time Frame
1- and 2-years
Title
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization
Time Frame
1- and 2-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabor G Toth, MD, PhD
Phone
004331638512544
Email
gabor.g.toth@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Peischl, BA
Phone
004331638581367
Email
Nicole.Peischl@klinikum-graz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabor G Toth, MD, PhD
Organizational Affiliation
Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zoltan Ruzsa, MD, PhD
Organizational Affiliation
Bacs-Kiskun County Hospital, Kecskemet, Hungary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Brodmann, MD, PhD
Organizational Affiliation
Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabor G Toth, MD, PhD
Phone
0043 316385 12 544
Email
gabor.g.toth@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Marianne Brodmann, MD, PhD
Facility Name
Bacs-Kiskun County Hospital
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoltan Ruzsa, MD, PhD
Email
zruzsa25@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31200280
Citation
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.
Results Reference
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Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia

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