Coronary Artery DiseaseCONFIGNCT04782492
IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit
A study testing graft configuration in coronary artery bypass grafting in people with Coronary Artery Disease and Morphologic Change, run by Ho Young Hwang at 1 site in South Korea.
Trial summary
Left internal thoracic artery (LITA) has been acknowledged as the first graft of choice for coronary artery bypass grafting (CABG). However, it is still not conclusive which one is the best second graft of choice among right internal thoracic artery, radial artery, right gastroepiploic artery, saphenous vein, and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Morphologic Change
- What is being tested?
- graft configuration in coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jul 2021to 27 Sep 2023
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient who is going to receive coronary artery bypass grafting
- Older than 19 years
- Coronary artery bypass grafting is going to be performed with left internal thoracic artery and saphenous vein graft
Who cannot join
- Other concomitant procedures (e.g. valve or aorta surgery) is planned
- Patients with severe comorbidities which limit the life expectancy of them below 1 year (e.g. terminal cancer)
- Patients whose left internal thoracic artery or saphenous vein is not available due to the low quality, severe injury, or absence of the graft
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morphologic Changes of the Saphenous Vein as Y-composite Graft Based on the Left Internal Thoracic Artery Versus Aortocoronary Conduit for Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Left internal thoracic artery (LITA) has been acknowledged as the first graft of choice for coronary artery bypass grafting (CABG). However, it is still not conclusive which one is the best second graft of choice among right internal thoracic artery, radial artery, right gastroepiploic artery, saphenous vein, and etc., as well as its configuration for CABG.
In our institution, saphenous vein has been primarily used for the second graft and we have harvested it with 'No touch technique'. We have been demonstrated the excellent long-term patency of this 'No touch saphenous vein' in many studies. However, it is still unknown which configuration is the better strategy for the saphenous vein as a Y-composite graft based on the left internal thoracic artery versus an aortocoronary conduit. Thus, we aimed to evaluate morphologic change of saphenous vein graft by 1-year intravascular ultrasound (IVUS) study and angiographic patency results between Y-composite graft and aortocoronary conduit.
Read the detailed description
The enrolled patient underwent routine sternotomy, and left internal thoracic artery (LITA) and saphenous vein (SV) are harvested. After harvest, the patient is randomized to Y-composite group or aortocoronary group.
For Y-composite group, SV is anastomosed to LITA as Y-composite fashion. Then, LITA is anastomosed to left anterior descending artery. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery).
For aortocoronary group, LITA is anastomosed to left anterior descending artery. Then, SV is anastomosed to ascending aorta using proximal anastomosis assist device without clamping the aorta. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery).
After completion of anastomoses, residual portion of distal SV is collected for microscopic evaluation and measurement of intima-media thickness.
At the 1-year follow-up, IVUS study, in addition to coronary angiography, is performed to evaluate the morphologic changes and measure intima-media thickness of the saphenous vein graft.
- Conditions
- Coronary Artery Disease, Morphologic Change
- Being tested
- graft configuration in coronary artery bypass grafting
- Keywords
- Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound
- 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.
graft configuration in coronary artery bypass graftingProcedure or surgery
Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| Y-composite graft | Experimental | The saphenous vein is anastomosed to the middle portion of the left internal thoracic artery as Y-composite fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. Receives: Procedure: graft configuration in coronary artery bypass grafting |
| aortocoronary conduit | Active comparator | The saphenous vein is anastomosed to the ascending aorta as aortocoronary fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. Receives: Procedure: graft configuration in coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intima-media thickness (IMT)
Intima-media thickness measured by intravascular ultrasound (IVUS)
Measured: at postoperative 1 year
Secondary outcomes (6)
Lumen diameter (LD)
Lumen diameter measured by intravascular ultrasound (IVUS)
Measured: at postoperative 1 year
Graft patency
Graft patency measured by coronary angiography
Measured: at postoperative 1 year
All cause mortality
all deaths from any cause
Measured: at postoperative 1 year
Cardiac death
Any death related to cardiac events, including sudden death during follow-up
Measured: at postoperative 1 year
Target vessel revascularization
The number of patients who received any intervention performed for the previously bypassed target vessel during follow-up
Measured: at postoperative 1 year
Reintervention
The number of patients who received any coronary intervention performed during follow-up due to the coronary artery disease
Measured: at postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start8 Jul 2021
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ho Young Hwang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ho Young Hwang, Seoul National University Hospital
- Investigators
- Ho Young Hwang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782492
- Sponsor's protocol ID
- H-2101-143-1191
- Acronym
- CONFIG
- Status last verified
- Apr 2024
- First submitted
- 2 Mar 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because it is not allowed by our Institutional Review Board.
Publications
Sohn SH, Kang Y, Kim JS, Kang J, Hwang HY. Morphologic changes of the no-touch saphenous vein as Y-composite versus aortocoronary grafts (CONFIG Trial). PLoS One. 2025 May 8;20(5):e0322176. doi: 10.1371/journal.pone.0322176. eCollection 2025.
PubMed 40338976
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphologic Changes of the Saphenous Vein as Y-composite Graft Based on the Left Internal Thoracic Artery Versus Aortocoronary Conduit for Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04782492
- Acronym / sponsor ID
- CONFIG / H-2101-143-1191
- Conditions
- Coronary Artery Disease, Morphologic Change
- Keywords
- Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ho Young HwangUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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.
Left internal thoracic artery (LITA) has been acknowledged as the first graft of choice for coronary artery bypass grafting (CABG). However, it is still not conclusive which one is the best second graft of choice among right internal thoracic artery, radial artery, right gastroepiploic artery, saphenous vein, and etc., as well as its configuration for CABG.
In our institution, saphenous vein has been primarily used for the second graft and we have harvested it with 'No touch technique'. We have been demonstrated the excellent long-term patency of this 'No touch saphenous vein' in many studies. However, it is still unknown which configuration is the better strategy for the saphenous vein as a Y-composite graft based on the left internal thoracic artery versus an aortocoronary conduit. Thus, we aimed to evaluate morphologic change of saphenous vein graft by 1-year intravascular ultrasound (IVUS) study and angiographic patency results between Y-composite graft and aortocoronary conduit.
Detailed description
The enrolled patient underwent routine sternotomy, and left internal thoracic artery (LITA) and saphenous vein (SV) are harvested. After harvest, the patient is randomized to Y-composite group or aortocoronary group.
For Y-composite group, SV is anastomosed to LITA as Y-composite fashion. Then, LITA is anastomosed to left anterior descending artery. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery).
For aortocoronary group, LITA is anastomosed to left anterior descending artery. Then, SV is anastomosed to ascending aorta using proximal anastomosis assist device without clamping the aorta. SV is anastomosed to the rest of the target vessels with sequential anastomosis technique (e.g. diagonal branch, obtuse marginal branch, posterolateral branch and posteriori descending artery).
After completion of anastomoses, residual portion of distal SV is collected for microscopic evaluation and measurement of intima-media thickness.
At the 1-year follow-up, IVUS study, in addition to coronary angiography, is performed to evaluate the morphologic changes and measure intima-media thickness of the saphenous vein graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
| Arm | Type | Receives |
|---|---|---|
| Y-composite graft | Experimental | Procedure: graft configuration in coronary artery bypass graftingThe saphenous vein is anastomosed to the middle portion of the left internal thoracic artery as Y-composite fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. |
| aortocoronary conduit | Active comparator | Procedure: graft configuration in coronary artery bypass graftingThe saphenous vein is anastomosed to the ascending aorta as aortocoronary fashion. Then, left anterior descending artery, if targeted, is bypassed with left internal thoracic artery. Other native coronary arterial targets are bypassed with saphenous vein graft. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A patient who is going to receive coronary artery bypass grafting
- Older than 19 years
- Coronary artery bypass grafting is going to be performed with left internal thoracic artery and saphenous vein graft
Key exclusion criteria (3 listed)
- Other concomitant procedures (e.g. valve or aorta surgery) is planned
- Patients with severe comorbidities which limit the life expectancy of them below 1 year (e.g. terminal cancer)
- Patients whose left internal thoracic artery or saphenous vein is not available due to the low quality, severe injury, or absence of the graft
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 |
|---|---|---|
| graft configuration in coronary artery bypass graftingSaphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting | Procedure or surgery | Y-composite graft, aortocoronary conduit |
Primary outcome
Intima-media thickness (IMT)
Time frame: at postoperative 1 year
Intima-media thickness measured by intravascular ultrasound (IVUS)
6 secondary outcomes
Lumen diameter (LD)
Time frame: at postoperative 1 year
Graft patency
Time frame: at postoperative 1 year
All cause mortality
Time frame: at postoperative 1 year
Cardiac death
Time frame: at postoperative 1 year
Target vessel revascularization
Time frame: at postoperative 1 year
Reintervention
Time frame: at postoperative 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Derived from this study: PubMed 40338976Sohn SH, Kang Y, Kim JS, Kang J, Hwang HY. Morphologic changes of the no-touch saphenous vein as Y-composite versus aortocoronary grafts (CONFIG Trial). PLoS One. 2025 May 8;20(5):e0322176. doi: 10.1371/journal.pone.0322176. eCollection 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because it is not allowed by our Institutional Review Board.
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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.
Ho Young Hwang, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graft configuration in coronary artery bypass grafting in people with Coronary Artery Disease and Morphologic Change, run by Ho Young Hwang 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 Apr 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intima-media thickness (IMT) (time frame: at postoperative 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782492, which also lists 1 linked publication.
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 19 Apr 2024.