Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics

NCT02355288 | Withdrawn DMC

• 1 other identifier: 20130910
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Diabetes Mellitus

Keywords

Coronary Artery Disease; Diabetes Mellitus; Minimally Invasive Cardiac Surgery; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (5)

• All-cause Mortality

  2 years

• Myocardial Infarction (MI)

  2 years

• Stroke

  2 years

• Target Vessel Revasularization (TVR)

  2 years

• Quality of Life (QOL)

  2 years

Study Arms (2)

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.

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.

Procedure: Percutenous Coronary Intervention

Interventions

Minimally Invasive Coronary Bypass PROCEDURE

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.

Minimally Invasive Coronary Bypass

Percutenous Coronary Intervention PROCEDURE

Stenting of the Left Anterior Descending (LAD) artery using a drug-eluting stent.

Percutenous Coronary Intervention

Eligibility Criteria

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

You may qualify if:

• Male or Female age 18 years or older
• Diabetes Mellitus (Type 1 or Type 2) undergoing treatment
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• University of Toronto: collaborator

MeSH Terms

Conditions

Coronary Artery Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marc A Ruel, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Division of Cardiac Surgery

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: February 4, 2015
• Study Start: October 1, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share