Graft Patency Analysis of the Right Coronary Artery System

April 3, 2019 updated by: Samsung Medical Center

Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery

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

5. Cardiac enzyme

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Graft occlusion
Time Frame: one year
Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (Estimate)

March 21, 2012

Study Record Updates

Last Update Posted (Actual)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-11-065

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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