Graft Patency Analysis of the Right Coronary Artery System

NCT ID: NCT01559350

Last Updated: 2019-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2018-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RGEA group

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

A right gastroepiploic artery in situ grafting

Intervention Type PROCEDURE

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

A saphenous vein grafting

Intervention Type PROCEDURE

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

Interventions

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A right gastroepiploic artery in situ grafting

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

Intervention Type PROCEDURE

A saphenous vein grafting

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Young Tak Lee, MD, PhD

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2011-11-065

Identifier Type: -

Identifier Source: org_study_id

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