Graft Patency Analysis of the Right Coronary Artery System

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01559350
First received: March 19, 2012
Last updated: March 10, 2013
Last verified: March 2012

March 19, 2012
March 10, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
All cause mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01559350 on ClinicalTrials.gov Archive Site
Graft occlusion [ Time Frame: one year ] [ Designated as safety issue: No ]
Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively
Same as current
Not Provided
Not Provided
 
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

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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Coronary Artery Disease
  • Procedure: A right gastroepiploic artery in situ grafting
    A right gastroepiploic artery in situ 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
  • RGEA group
    A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
    Intervention: Procedure: A right gastroepiploic artery in situ grafting
  • SVG group
    A saphenous vein grafting in the right coronary artery system during OPCAB
    Intervention: Procedure: A saphenous vein grafting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
224
December 2022
December 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact: Dong Seop Jeong, MD, PhD 82-2-3410-1278 cabg.jeong@samsung.net
Korea, Republic of
 
NCT01559350
2011-11-065
Yes
Samsung Medical Center
Samsung Medical Center
Not Provided
Study Director: Young Tak Lee, MD, PhD Samsung Medical Center
Samsung Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP