WithdrawnNot Applicable

Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics

Stopped: Insufficient funding available to complete study.

0Started 2018-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ste…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Successfully enrolled, eligible and consenting patients within the first year of enrollment.

Timeframe: 1 year

Trial details

NCT IDNCT02355288

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-01

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