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Graft Patency Analysis of the Right Coronary Artery System

Sponsor
Samsung Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT01559350
Collaborator
(none)
50
Enrollment
1
Location
83
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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

  6. Cardiac enzyme

Condition or Disease Intervention/Treatment Phase
  • Procedure: A right gastroepiploic artery in situ grafting
  • Procedure: A saphenous vein grafting

Detailed Description

The ideal bypass conduit for the right coronary artery remains a subject of intense controversy. A variety of grafts and configurations are used: the right gastroepiploic artery,the right internal thoracic artery in situ or in a Y-graft configuration,the free radial artery implanted into the aorta or the left internal thoracic artery, and the saphenous vein graft. The influence of the type of graft to the right coronary artery system on clinical results remains poorly documented, and the complementary conduit of choice to this system has yet to be determined. No superior long-term patency rate for any of these grafts to the RCA has been clearly established. We have used a saphenous vein and a right gastroepiploic artery for the right coronary artery system.

Study Design

Study Type:
Observational
Actual Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery
Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
RGEA group

A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB

Procedure: A right gastroepiploic artery in situ grafting
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

Procedure: A saphenous vein grafting
A saphenous vein grafting in the right coronary artery system during OPCAB

Outcome Measures

Primary Outcome Measures

  1. All cause mortality [one year]

Secondary Outcome Measures

  1. Graft occlusion [one year]

    Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 135-710

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Study Director: Young Tak Lee, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01559350
Other Study ID Numbers:
  • 2011-11-065
First Posted:
Mar 21, 2012
Last Update Posted:
Apr 5, 2019
Last Verified:
Mar 1, 2012
Keywords provided by Samsung Medical Center
OPCAB
Additional relevant MeSH terms:
Coronary Artery Disease

Study Results

No Results Posted as of Apr 5, 2019