Coronary Artery DiseaseNCT01559350
Graft Patency Analysis of the Right Coronary Artery System
An observational study of Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- A right gastroepiploic artery in situ grafting and A saphenous vein grafting
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2012to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Laboratories
- Quantitative coronary analysis (preoperative)
- Major adverse cardiac and cerebrovascular event
- coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively
- Echocardiogram
- Cardiac enzyme
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- A right gastroepiploic artery in situ grafting, A saphenous vein grafting
- Keywords
- OPCAB
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A right gastroepiploic artery in situ graftingProcedure or surgery
A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
A saphenous vein graftingProcedure or surgery
A saphenous vein grafting in the right coronary artery system during OPCAB
| Study group | Role | What they receive |
|---|---|---|
| RGEA group | A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB Receives: Procedure: A right gastroepiploic artery in situ grafting | |
| SVG group | A saphenous vein grafting in the right coronary artery system during OPCAB Receives: Procedure: A saphenous vein grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: one year
Secondary outcomes (1)
Graft occlusion
Coronary CT follow up at discharge, 1, 5 and 10 years postoperatively
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2018
Why it stopped: Poor recruiting rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Tak Lee, MD, PhD, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559350
- Sponsor's protocol ID
- 2011-11-065
- Status last verified
- Mar 2012
- First submitted
- 19 Mar 2012
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graft Patency of the Right Coronary Artery System in OPCAB: Saphenous Vein Graft Versus Right Gastroepiploic Artery
- ClinicalTrials.gov ID
- NCT01559350
- Acronym / sponsor ID
- 2011-11-065
- Conditions
- Coronary Artery Disease
- Keywords
- OPCAB
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor recruiting rate
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Laboratories
- Quantitative coronary analysis (preoperative)
- Major adverse cardiac and cerebrovascular event
- coronary CT (coronary angiography if needed) at discharge, 1, 5, 10 years postoperatively
- Echocardiogram
- Cardiac enzyme
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGEA group | – | Procedure: A right gastroepiploic artery in situ graftingA right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB |
| SVG group | – | Procedure: A saphenous vein graftingA saphenous vein grafting in the right coronary artery system during OPCAB |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo OPCAB for triple vessel disease at Samsung Medical Center are enrolled.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- History of upper abdomen surgery
- History of upper GI bleeding
- Active gastric or duodenal ulcer
- Body mass index > 35kg/m2
- Redo surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A right gastroepiploic artery in situ graftingA right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB | Procedure or surgery | RGEA group |
| A saphenous vein graftingA saphenous vein grafting in the right coronary artery system during OPCAB | Procedure or surgery | SVG group |
Primary outcome
All cause mortality
Time frame: one year
1 secondary outcome
Graft occlusion
Time frame: one year
Results and safety
The study was stopped early (reason given: Poor recruiting rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Tak Lee, MD, PhD study director
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor recruiting rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.