Coronary Artery DiseaseLIBERTINCT02355288
Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics
A study testing Minimally Invasive Coronary Bypass and Percutenous Coronary Intervention in people with Coronary Artery Disease and Diabetes Mellitus, run by Ottawa Heart Institute Research Corporation.
Trial summary
The purpose of this study is to evaluate whether less invasive bypass surgery using the left chest wall artery is more or less effective than inserting a heart stent in patients with diabetes and a blockage of the main artery at the front of the heart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Diabetes Mellitus
- What is being tested?
- Minimally Invasive Coronary Bypass and Percutenous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Oct 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female age 18 years or older
- Diabetes Mellitus (Type 1 or Type 2) undergoing treatment
- Angiographically confirmed stenosis (≥ 70%) lesion of the proximal LAD (segment 6) or mid LAD (segment 7), with no culprit lesion or stenosis of more than 60% (in a vessel of 1.5 mm or more) in the LCX and RCA territories, and no stenosis equal or more than 50% in the left main artery. Diagonal disease does not constitute an exclusion
- Angiographic characteristics amenable to both PCI/DES and MICS CABG
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
- Willing to comply with all follow-up required study visits
- Signed and received copy of informed consent
Who cannot join
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- Left ventricular ejection fraction less than 20%;
- Prior CABG surgery.
- Prior Valve surgery.
- Prior PCI with stent implantation within 6 months.
- Previous tuberculosis or trauma to the chest that may have cause adhesions or LITA damage.
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- Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1.
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- In-stent restenosis in the LAD.
- Left main stenosis (50% or more).
- STEMI or Q-wave MI within 72 hours prior to enrollment
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
- Contraindication to either CABG or PCI/DES because of a coexisting clinical condition.
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- Intolerance or contraindication to aspirin or both clopidogrel and ticagrelor.
- Dementia with a Mini Mental Status Examination (MMSE) score of <20.
- Extra-cardiac illness that is expected to limit survival to less than 5 years.
- Suspected pregnancy. A pregnancy test (urine or serum) will be administered pre-randomization to all women not clearly menopausal.
- Concurrent enrollment in another clinical trial.
- Geographically inaccessible for follow-up visits required by protocol.
About this study
Official title: Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics:Is Minimally Invasive Left Internal Thoracic Artery Bypass Superior to Percutaneous Revascularization in Diabetic Patients With Isolated LAD Stenosis?
The purpose of this study is to evaluate whether less invasive bypass surgery using the left chest wall artery is more or less effective than inserting a heart stent in patients with diabetes and a blockage of the main artery at the front of the heart. This will be a clinical trial study where the investigators will test the rate of recruitment into the study, as well as the feasibility of allocating each of the 2 treatments.
Read the detailed description
Purpose/Objectives:
The purpose of this pilot study is to evaluate whether minimally invasive bypass surgery with the left internal thoracic artery (MICS CABG) is more or less effective than percutaneous revascularization with drug eluting stents (PCI/DES) in patients with diabetes and stenosis of the left anterior descending (LAD) artery.
Population:
The investigators will recruit 100 adults with diabetes mellitus (Type 1 or Type 2) and angiographically-confirmed proximal or mid LAD disease, morphologically amenable to either MICS CABG or PCI/DES; outside the context of an acute ST-elevation myocardial infarction, and with indication for revascularization based upon symptoms of worsening angina and/or objective evidence of myocardial ischemia.
Design:
This trial is a multicentre, two-arm, open label, prospective, randomized, pilot trial over a duration of 2.75 years, with 0.75 year of initiation, 1 year of patient recruitment and 2 years of follow-up. Patients who consent will be randomized on a 1:1 basis either to MICS CABG or PCI/DES of the LAD, and followed at 30 days, 6 months, 1 year, 18 months, and 2 years.
Treatment:
Eligible patients will be randomized to receive either MICS CABG or PCI/DES to the LAD. Patients randomized to the PCI/DES arm will receive, at the discretion of the primary physician or interventionalist, the stent of choice at the treating institution, with a recommendation of a everolimus- or zotarolimus-eluting stent.
Primary Endpoint:
The primary endpoint is successfully enrolled, eligible and consenting patients within the first year of enrollment, with success defined as 100 patients or more.
Secondary Endpoints:
All-cause mortality, Myocardial Infarction (MI), stroke and target vessel revascularization (TVR) will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Quality of Life (QOL) at 1 month, 6 months, 1 year, 18 months, and 2 year will be compared for the therapy comparison PCI/DES vs. MICS CABG. Patients will be asked to complete the following questionnaires: the EuroQOL (EQ-5D) and Seattle Angina Questionnaire (SAQ).
Statistics:
The main feasibility questions are: "can the investigators enroll a sizable number of patients at a given centre over a 1 year period?", "can the investigators implement and conduct the proposed trial across multiple centres?", and "can the investigators ensure high protocol adherence and follow-up, as well as minimize crossovers?". By enrolling 100 participants across 5 sites over 1 year, and follow them.
For each therapy group, the frequency distribution each of the domains of the EQ5D will be tabulated and the mean, standard deviation, median and interquartile range (IQR) calculated. Therapy groups will be compared on these outcomes using the t-test or the Wilcoxon rank-sum test and 95%CI calculated. Repeated measures ANOVA will compare the two therapy groups on changes in health related QOL over time
Participating Centres:
The investigators have chosen 5 study sites in Canada (3) and in the United States (2). The recruitment goal for each site is to enroll at least 20 patients.
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Being tested
- Minimally Invasive Coronary Bypass, Percutenous Coronary Intervention
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Minimally Invasive Cardiac Surgery, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Coronary BypassProcedure or surgery
Bypass graft of the Left Anterior Descending (LAD) artery using minimally invasive cardiac surgery. MICS is a bypass surgery done with a small (4-6 cm) incision under the left breast, instead of the usual incision down the middle the chest.
Percutenous Coronary InterventionProcedure or surgery
Stenting of the Left Anterior Descending (LAD) artery using a drug-eluting stent.
| Study group | Role | What they receive |
|---|---|---|
| Minimally Invasive Coronary Bypass | Active comparator | Minimally invasive bypass surgery (MICS CABG) would be conducted to treat the left anterior descending (LAD) artery disease in diabetic patients. This would be a surgical intervention, and differs from the stent procedure arm. Receives: Procedure: Minimally Invasive Coronary Bypass |
| Percutenous Coronary Intervention | Active comparator | Percutaneous coronary intervention (PCI) with drug eluting stents would be used to treat left anterior descending (LAD) artery disease in diabetic patients. This would be an intervention induced by cardiology, and differs from the surgical intervention arm. Receives: Procedure: Percutenous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successfully enrolled, eligible and consenting patients within the first year of enrollment.
To determine the feasibility of the study by successfully recruiting 100 patients within the 1 year recruitment period.
Measured: 1 year
Secondary outcomes (5)
All-cause Mortality
All-cause mortality will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Measured: 2 years
Myocardial Infarction (MI)
MI will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Measured: 2 years
Stroke
Stroke will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Measured: 2 years
Target Vessel Revasularization (TVR)
TVR will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Measured: 2 years
Quality of Life (QOL)
QOL at 1 month, 6 months, 1 year, 18 months, and 2 year will be compared for the therapy comparison PCI/DES vs. MICS CABG. Patients will undergo the following QOL questionnaires at each time point above: The EuroQOL (EQ-5D), Seattle Angina Questionnaire, (SAQ).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study start1 Oct 2018 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Why it stopped: Insufficient funding available to complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation
- Investigators
- Marc A Ruel, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355288
- Sponsor's protocol ID
- 20130910
- Acronym
- LIBERTI
- Status last verified
- Apr 2018
- First submitted
- 8 Dec 2014
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other researchers/institutions unless a contract or agreement is determined.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics:Is Minimally Invasive Left Internal Thoracic Artery Bypass Superior to Percutaneous Revascularization in Diabetic Patients With Isolated LAD Stenosis?
- ClinicalTrials.gov ID
- NCT02355288
- Acronym / sponsor ID
- LIBERTI / 20130910
- Conditions
- Coronary Artery Disease, Diabetes Mellitus
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Minimally Invasive Cardiac Surgery, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding available to complete study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- 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 purpose of this study is to evaluate whether less invasive bypass surgery using the left chest wall artery is more or less effective than inserting a heart stent in patients with diabetes and a blockage of the main artery at the front of the heart. This will be a clinical trial study where the investigators will test the rate of recruitment into the study, as well as the feasibility of allocating each of the 2 treatments.
Detailed description
Purpose/Objectives:
The purpose of this pilot study is to evaluate whether minimally invasive bypass surgery with the left internal thoracic artery (MICS CABG) is more or less effective than percutaneous revascularization with drug eluting stents (PCI/DES) in patients with diabetes and stenosis of the left anterior descending (LAD) artery.
Population:
The investigators will recruit 100 adults with diabetes mellitus (Type 1 or Type 2) and angiographically-confirmed proximal or mid LAD disease, morphologically amenable to either MICS CABG or PCI/DES; outside the context of an acute ST-elevation myocardial infarction, and with indication for revascularization based upon symptoms of worsening angina and/or objective evidence of myocardial ischemia.
Design:
This trial is a multicentre, two-arm, open label, prospective, randomized, pilot trial over a duration of 2.75 years, with 0.75 year of initiation, 1 year of patient recruitment and 2 years of follow-up. Patients who consent will be randomized on a 1:1 basis either to MICS CABG or PCI/DES of the LAD, and followed at 30 days, 6 months, 1 year, 18 months, and 2 years.
Treatment:
Eligible patients will be randomized to receive either MICS CABG or PCI/DES to the LAD. Patients randomized to the PCI/DES arm will receive, at the discretion of the primary physician or interventionalist, the stent of choice at the treating institution, with a recommendation of a everolimus- or zotarolimus-eluting stent.
Primary Endpoint:
The primary endpoint is successfully enrolled, eligible and consenting patients within the first year of enrollment, with success defined as 100 patients or more.
Secondary Endpoints:
All-cause mortality, Myocardial Infarction (MI), stroke and target vessel revascularization (TVR) will be compared for the therapy comparison PCI/DES versus MICS CABG. For these analyses, the survival analysis outlined for the primary analysis will be followed.
Quality of Life (QOL) at 1 month, 6 months, 1 year, 18 months, and 2 year will be compared for the therapy comparison PCI/DES vs. MICS CABG. Patients will be asked to complete the following questionnaires: the EuroQOL (EQ-5D) and Seattle Angina Questionnaire (SAQ).
Statistics:
The main feasibility questions are: "can the investigators enroll a sizable number of patients at a given centre over a 1 year period?", "can the investigators implement and conduct the proposed trial across multiple centres?", and "can the investigators ensure high protocol adherence and follow-up, as well as minimize crossovers?". By enrolling 100 participants across 5 sites over 1 year, and follow them.
For each therapy group, the frequency distribution each of the domains of the EQ5D will be tabulated and the mean, standard deviation, median and interquartile range (IQR) calculated. Therapy groups will be compared on these outcomes using the t-test or the Wilcoxon rank-sum test and 95%CI calculated. Repeated measures ANOVA will compare the two therapy groups on changes in health related QOL over time
Participating Centres:
The investigators have chosen 5 study sites in Canada (3) and in the United States (2). The recruitment goal for each site is to enroll at least 20 patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Coronary Bypass | Active comparator | Procedure: Minimally Invasive Coronary BypassMinimally invasive bypass surgery (MICS CABG) would be conducted to treat the left anterior descending (LAD) artery disease in diabetic patients. This would be a surgical intervention, and differs from the stent procedure arm. |
| Percutenous Coronary Intervention | Active comparator | Procedure: Percutenous Coronary InterventionPercutaneous coronary intervention (PCI) with drug eluting stents would be used to treat left anterior descending (LAD) artery disease in diabetic patients. This would be an intervention induced by cardiology, and differs from the surgical intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or Female age 18 years or older
- Diabetes Mellitus (Type 1 or Type 2) undergoing treatment
- Angiographically confirmed stenosis (≥ 70%) lesion of the proximal LAD (segment 6) or mid LAD (segment 7), with no culprit lesion or stenosis of more than 60% (in a vessel of 1.5 mm or more) in the LCX and RCA territories, and no stenosis equal or more than 50% in the left main artery. Diagonal disease does not constitute an exclusion
- Angiographic characteristics amenable to both PCI/DES and MICS CABG
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
Key exclusion criteria (20 listed)
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- Left ventricular ejection fraction less than 20%;
- Prior CABG surgery.
- Prior Valve surgery.
- Prior PCI with stent implantation within 6 months.
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 |
|---|---|---|
| Minimally Invasive Coronary BypassBypass graft of the Left Anterior Descending (LAD) artery using minimally invasive cardiac surgery. MICS is a bypass surgery done with a small (4-6 cm) incision under the left breast, instead of the usual incision down the middle the chest. | Procedure or surgery | Minimally Invasive Coronary Bypass |
| Percutenous Coronary InterventionStenting of the Left Anterior Descending (LAD) artery using a drug-eluting stent. | Procedure or surgery | Percutenous Coronary Intervention |
Primary outcome
Successfully enrolled, eligible and consenting patients within the first year of enrollment.
Time frame: 1 year
To determine the feasibility of the study by successfully recruiting 100 patients within the 1 year recruitment period.
5 secondary outcomes
All-cause Mortality
Time frame: 2 years
Myocardial Infarction (MI)
Time frame: 2 years
Stroke
Time frame: 2 years
Target Vessel Revasularization (TVR)
Time frame: 2 years
Quality of Life (QOL)
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers/institutions unless a contract or agreement is determined.
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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.
Marc A Ruel, MD principal investigator
Ottawa Heart Institute Research Corporation
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Coronary Bypass and Percutenous Coronary Intervention in people with Coronary Artery Disease and Diabetes Mellitus, run by Ottawa Heart Institute Research Corporation.
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 7 inclusion and 20 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: withdrawn, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successfully enrolled, eligible and consenting patients within the first year of enrollment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.