Left Internal Thoracic Artery Bypass Versus Percutaneous Revascularization in Diabetics (NCT02355288) | Clinical Trial Compass
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 range18 Years
SexALL
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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…
What they're measuring
1
Successfully enrolled, eligible and consenting patients within the first year of enrollment.
Timeframe: 1 year
Trial details
NCT IDNCT02355288
SponsorOttawa Heart Institute Research Corporation