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Total arterial grafting versus internal mammary and saphenous vein grafting for coronary artery bypass graft surgery

A randomised clinical trial comparing total arterial grafting versus internal mammary and saphenous vein grafting for coronary artery bypass graft surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN80270323
Enrollment
60
Registered
2009-12-08
Start date
2009-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic heart disease Circulatory System Chronic ischaemic heart disease

Interventions

Consented patients will undergo CABG surgery using TAG (experimental group) or LIMA/SV (control group) based on the randomisation assignment and followed for 6 months post surgery with coronary angiog

Sponsors

Capital Health Authority, New Halifax Infirmary (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Consecutive patients between the ages of 60 and 75 years of age*, either sex 2. Undergoing non-emergent isolated CABG surgery for 3 vessel coronary disease 3. Have not already been enrolled in another study *The average age of patients undergoing CABG surgery at the QEII is approximately 70 with 50% of patients between the age restrictions. The age limit of 75 is an attempt at increasing long-term follow-up of patients which would be limited in octogenarians.

Exclusion criteria

Exclusion criteria: 1. Scheduled to undergo emergency or emergency salvage surgery 2. Angiographically ungraftable coronary territories 3. Prior surgical coronary revascularisation 4. Evidence of varicose veins on pre-operative physical examination which would preclude the use of the greater saphenous vein as a graft conduit 5. Previous radiation treatment to their chest area (which would make the utility of internal mammary arteries questionable) 6. Relative contraindications to computed tomography (CT) angiography such as pregnancy, chronic renal insufficiency (creatinine greater than 120 umol/L), or allergy to contrast media

Design outcomes

Primary

MeasureTime frame
Six-month graft patency in patients who undergo TAG compared to those who undergo conventional coronary artery revascularisation with LIMA/SV grafts. Grafts will be assessed as patent, occluded or stenosed greater than 50%. For grafts with sequentially supply more than one vessel, each inter-anastomotic segment will be assessed separately.

Secondary

MeasureTime frame
Rates of adverse cardiovascular events in patients who undergo TAG compared to those who undergo conventional coronary artery revascularisation with LIMA/SV grafts. Results will be reported separately and as composite outcomes. Adverse cardiovascular events will be defined as: 1. Short term event: in-hospital mortality and in-hospital morbidity: 1.1. All cause mortality with the cause of death recorded 1.2. Morbidity: peri-operative myocardial infarction, re-intervention (percutaneous coronary intervention [PCI] or CABG), low output syndrome, prolonged mechanical ventilation, sternal wound infection and prolonged length of hospitalisation 2. Late adverse cardiovascular events defined as: 2.1. All cause mortality 2.2. Readmission to hospital for cardiac reason

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026