Graft Patency Analysis of the Right Coronary Artery System

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01559350
• Other study ID #: 2011-11-065
• Status: Terminated
• Start date: January 2012
• Est. completion date: December 2018

Study information

• Verified date: March 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

5. Cardiac enzyme

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		one year
Secondary	Graft occlusion	Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively	one year