N/A N=224 Randomized Single-blind Treatment

A Prospective Randomized Study for Comparison of Y-Composite Grafts

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT01051986 ↗

Enrolled (actual)

224

Serious AEs

6.3%

Results posted

Jan 2014

Primary outcome: Primary: 1 Year Graft Patency Rates — 97.1; 97.1 percentage of distal anastomoses

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: saphenous vein composite grafting (Procedure); right internal thoracic artery composite grafting (Procedure)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY 1 Year Graft Patency Rates	97.1; 97.1	—
SECONDARY Overall Survival	97.8; 97.6	—
SECONDARY Freedom From Cardiac Death	100; 99.1	—
SECONDARY Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)	91.1; 94.4	—
SECONDARY Early Angiographic Patency Rates	99.5; 98.8	—

Summary

The purpose of this study is to compare early and 1-year graft patency rates of saphenous vein composite grafts with those of right internal thoracic artery composite graft and mid-term clinical outcomes in patients who undergo off-pump coronary artery bypass grafting(OPCAB). We also evaluate microscopic findings of saphenous vein graft harvested no touch technique and used as composite graft.

Eligibility Criteria

Inclusion Criteria

age equal or more than 40
age equal or less than 75
patients who agree to the enrollment

Exclusion Criteria

Patients with heart failure (left ventricular ejection fraction < 25%)
patients who have intractable ventricular arrhythmia
patients who has been treated for cancer
patients who has infectious disease
patients who are planned to undergo combined cardiac surgery
patients who has medical co-morbidity with expected survival less than 1 year
patients who has a problem using right internal thoracic artery or saphenous vein
patients with a history of previous cardiac surgery
Patients with chronic renal failure
patients who undergo emergency operation

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01051986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.