IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit

NCT ID: NCT04782492

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-08
• Study Completion Date: 2023-09-27

Brief 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 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.

Conditions

Coronary Artery Disease; Morphologic Change

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Y-composite graft

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.

Group Type: EXPERIMENTAL

graft configuration in coronary artery bypass grafting

Intervention Type: PROCEDURE

Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting

aortocoronary conduit

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.

Group Type: ACTIVE_COMPARATOR

graft configuration in coronary artery bypass grafting

Intervention Type: PROCEDURE

Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting

Interventions

graft configuration in coronary artery bypass grafting

Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ho Young Hwang

OTHER

Sponsor Role: lead

Responsible Party

Ho Young Hwang

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ho Young Hwang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 40338976 (View on PubMed)

Other Identifiers

H-2101-143-1191

Identifier Type: -

Identifier Source: org_study_id