Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 78 of 245 for:    "ottawa heart institute"

Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics (LIBERTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02355288
Recruitment Status : Withdrawn (Insufficient funding available to complete study.)
First Posted : February 4, 2015
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
University of Toronto
Information provided by (Responsible Party):
Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Diabetes Mellitus Procedure: Minimally Invasive Coronary Bypass Procedure: Percutenous Coronary Intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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?
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Arm Intervention/treatment
Active Comparator: Minimally Invasive Coronary Bypass
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.
Procedure: Minimally Invasive Coronary Bypass
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.

Active Comparator: Percutenous Coronary Intervention
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.
Procedure: Percutenous Coronary Intervention
Stenting of the Left Anterior Descending (LAD) artery using a drug-eluting stent.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. All-cause Mortality [ Time Frame: 2 years ]
    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.

  2. Myocardial Infarction (MI) [ Time Frame: 2 years ]
    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.

  3. Stroke [ Time Frame: 2 years ]
    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.

  4. Target Vessel Revasularization (TVR) [ Time Frame: 2 years ]
    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.

  5. Quality of Life (QOL) [ Time Frame: 2 years ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355288


Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
University of Toronto
Investigators
Layout table for investigator information
Principal Investigator: Marc A Ruel, MD Ottawa Heart Institute Research Corporation

Layout table for additonal information
Responsible Party: Marc Ruel MD MPH FRCSC, Professor and Chairman, Division of Cardiac Surgery, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT02355288     History of Changes
Other Study ID Numbers: 20130910
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared with other researchers/institutions unless a contract or agreement is determined.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation:
Coronary Artery Disease
Diabetes Mellitus
Minimally Invasive Cardiac Surgery
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases