Coronary Artery DiseaseCONFIG2NCT05704296
Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG
A study testing Y-composite grafting and Aortocoronary grafting in people with Coronary Artery Disease, 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
- What is being tested?
- Y-composite grafting and Aortocoronary grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Apr 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients whose ascending aorta is not suitable to aortocoronary anastomosis (e.g. ascending aorta aneurysm, porcelain aorta)
- Emergency operation
- Patients who have connective tissue disease
- Reoperative coronary artery bypass grafting
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Ho Young Hwang, MD, PhD, 82-2-2072-3020, scalpel@snu.ac.kr
Suk Ho Sohn, MD, 82-2-2072-1949, shsohn@snu.ac.kr
About this study
Official title: Comparison Between 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 posterior 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).
At 1-year follow-up, coronary angiography is performed to evaluate the patency of the saphenous vein graft. Clinical outcomes are also evaluated.
- Conditions
- Coronary Artery Disease
- Being tested
- Y-composite grafting, Aortocoronary grafting
- Keywords
- coronary artery bypass grafting, saphenous vein, coronary angiography
- 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.
Y-composite graftingProcedure or surgery
Saphenous vein is used as a Y-composite graft during coronary artery bypass grafting
Aortocoronary graftingProcedure or surgery
Saphenous vein is used as an aortocoronary graft during coronary artery bypass grafting
| Study group | Role | What they receive |
|---|---|---|
| Y-composite grafting | 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: Y-composite grafting |
| Aortocoronary grafting | 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: Aortocoronary grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency
Graft patency measured by coronary angiography
Measured: at postoperative 1 year
Secondary outcomes (5)
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
Intervention performed for the previously bypassed target vessel during follow-up
Measured: at postoperative 1 year
Reintervention
Any coronary intervention performed during follow-up due to the coronary artery disease
Measured: at postoperative 1 year
Major Adverse Cardiac Events (MACEs)
acute myocardial infarction, coronary reintervention, and cardiac death including sudden death during follow-up
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 posted30 Jan 2023
- Study start18 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
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.
- 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
- 290 participants (estimated)
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
- NCT05704296
- Sponsor's protocol ID
- H-2211-023-1376
- Acronym
- CONFIG2
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2023
- Last updated
- 17 Sep 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 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
- NCT05704296
- Acronym / sponsor ID
- CONFIG2 / H-2211-023-1376
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass grafting, saphenous vein, coronary angiography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Ho Young HwangUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 30 Jan 2023 (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 posterior 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).
At 1-year follow-up, coronary angiography is performed to evaluate the patency of the saphenous vein graft. Clinical outcomes are also evaluated.
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 grafting | Experimental | Procedure: Y-composite 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 grafting | Active comparator | Procedure: Aortocoronary 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 (7 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
- Patients whose ascending aorta is not suitable to aortocoronary anastomosis (e.g. ascending aorta aneurysm, porcelain aorta)
- Emergency operation
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 |
|---|---|---|
| Y-composite graftingSaphenous vein is used as a Y-composite graft during coronary artery bypass grafting | Procedure or surgery | Y-composite grafting |
| Aortocoronary graftingSaphenous vein is used as an aortocoronary graft during coronary artery bypass grafting | Procedure or surgery | Aortocoronary grafting |
Primary outcome
Graft patency
Time frame: at postoperative 1 year
Graft patency measured by coronary angiography
5 secondary outcomes
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
Major Adverse Cardiac Events (MACEs)
Time frame: at postoperative 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
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 Y-composite grafting and Aortocoronary grafting in people with Coronary Artery Disease, 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 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho Young Hwang, MD, PhD (00-82-10-4004-3673, scalpel@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency (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?
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 17 Sep 2026.