Study Stopped
Poor recruiting rate
Graft Patency Analysis of the Right Coronary Artery System
Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery
1 other identifier
observational
50
1 country
1
Brief Summary
The ideal grafts for the right coronary artery system in coronary artery bypass surgery remain controversial. The objective of this study is to compare the long-term patency of a right gastroepiploic artery and a saphenous vein graft used for revascularization of the right coronary artery system in off pump coronary artery bypass surgery and to analyze the long-term clinical outcomes. Total 224 patients will be enrolled according to the randomization protocol. Check list
- 1.Laboratories
- 2.Quantitative coronary analysis (preoperative)
- 3.Major adverse cardiac and cerebrovascular event
- 4.coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively
- 5.Echocardiogram
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 5, 2019
March 1, 2012
3.9 years
March 19, 2012
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
one year
Secondary Outcomes (1)
Graft occlusion
one year
Study Arms (2)
RGEA group
A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
SVG group
A saphenous vein grafting in the right coronary artery system during OPCAB
Interventions
A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
A saphenous vein grafting in the right coronary artery system during OPCAB
Eligibility Criteria
Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.
You may qualify if:
- Angiographic evidence of severe coronary stenosis on the right coronary territory
- Elective surgery
- Isolated off pump CABG
- Age \< 75 years and life expectancy \> 5 years
- Preoperative RGEA diameter \> 1.5mm
- Normal left ventricular function
You may not qualify if:
- History of upper abdomen surgery
- History of upper GI bleeding
- Active gastric or duodenal ulcer
- Body mass index \> 35kg/m2
- Redo surgery
- Presence of varicose vein
- Contraindication for CABG such as malignancy or liver cirrhosis
- Other configuration than RGEA to RCA territory or SVG to RCA territory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Young Tak Lee, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 21, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2015
Study Completion
December 1, 2018
Last Updated
April 5, 2019
Record last verified: 2012-03