Obstructive Coronary Artery DiseaseINCORPORATENCT03712644
Coronary Revascularization Versus Conservative Therapy in Patients With Treated Critical Limb Ischemia
A study testing FFR-guided coronary revascularization in people with Obstructive Coronary Artery Disease, run by Medical University of Graz at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Obstructive Coronary Artery Disease
- What is being tested?
- FFR-guided coronary revascularization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Jul 2018to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Austria1 site, 1 recruiting
- Recruiting
Div. Cardiology and Div. Angiology, Dept. Medicine, Medical University Graz
Graz, 8036
Gabor G Toth, MD, PhD, 0043 316385 12 544, gabor.g.toth@medunigraz.at
Marianne Brodmann, MD, PhD
Hungary1 site, 1 recruiting
- Recruiting
Bacs-Kiskun County Hospital
Kecskemét, 6000
Zoltan Ruzsa, MD, PhD, zruzsa25@gmail.com
About this study
Official title: Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
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
- Being tested
- FFR-guided coronary revascularization
- Keywords
- Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFR-guided coronary revascularizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FFR-guided coronary revascularization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite of overall death and spontaneous myocardial infarction
Measured: 1-year
Secondary outcomes (6)
Rate of composite of overall death and spontaneous myocardial infarction
Measured: 2-years
Rate of overall death
Measured: 1- and 2-years
Rate of spontaneous myocardial infarction
Measured: 1- and 2-years
Quality of life (EQ5D) development
Measured: 1- and 2-years
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization and any stroke
Measured: 1- and 2-years
Rate of composite of death, spontaneous myocardial infarction, target coronary revascularization
Measured: 1- and 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start11 Jul 2018
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabor Toth-Gayor, Medical University of Graz
- Investigators
- Gabor G Toth, MD, PhD, Principal investigator, Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, AustriaZoltan Ruzsa, MD, PhD, Principal investigator, Bacs-Kiskun County Hospital, Kecskemet, HungaryMarianne Brodmann, MD, PhD, Principal investigator, Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712644
- Sponsor's protocol ID
- 30-194 ex 17/18
- Acronym
- INCORPORATE
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38990250Toth 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.
PubMed 31200280
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intentional Coronary Revascularization Versus Conservative Therapy in Patients Undergoing Peripheral Artery Revascularization Due to Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT03712644
- Acronym / sponsor ID
- INCORPORATE / 30-194 ex 17/18
- Conditions
- Obstructive Coronary Artery Disease
- Keywords
- Critical limb ischemia, Coronary artery disease, Fractional flow reserve-guided coronary revascularization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non-blinded, open-label, prospective 1:1 randomized controlled multicentric trial.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: FFR-guided coronary revascularizationIn 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFR-guided coronary revascularizationStenoses 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. | Device | Invasive |
Primary outcome
Rate of composite of overall death and spontaneous myocardial infarction
Time frame: 1-year
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
- Derived from this study: PubMed 38990250Toth 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.
- Derived from this study: PubMed 31200280Toth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabor G Toth, MD, PhD principal investigator
Div. Cardiology, Dept. Medicine, Medical University Graz, Graz, Austria
Zoltan Ruzsa, MD, PhD principal investigator
Bacs-Kiskun County Hospital, Kecskemet, Hungary
Marianne Brodmann, MD, PhD principal investigator
Div. Angiology, Dept. Medicine, Medical University Graz, Graz, Austria
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR-guided coronary revascularization in people with Obstructive Coronary Artery Disease, run by Medical University of Graz at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabor G Toth, MD, PhD (004331638512544, gabor.g.toth@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of composite of overall death and spontaneous myocardial infarction (time frame: 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03712644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.