Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG

NCT ID: NCT05704296

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 290 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-18
• Study Completion Date: 2028-01-31

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 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

Study Design

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

Study Groups

Y-composite grafting

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

Y-composite grafting

Intervention Type: PROCEDURE

Saphenous vein is used as a Y-composite graft during coronary artery bypass grafting

Aortocoronary grafting

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

Aortocoronary grafting

Intervention Type: PROCEDURE

Saphenous vein is used as an aortocoronary graft during coronary artery bypass grafting

Interventions

Y-composite grafting

Saphenous vein is used as a Y-composite graft during coronary artery bypass grafting

Intervention Type: PROCEDURE

Aortocoronary grafting

Saphenous vein is used as an aortocoronary graft 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
• 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

• 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

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ho Young Hwang, MD, PhD

Role: CONTACT

scalpel@snu.ac.kr

00-82-10-4004-3673

Suk Ho Sohn, MD

Role: CONTACT

shsohn@snu.ac.kr

00-82-10-9114-3168

Facility Contacts

Ho Young Hwang, MD, PhD

Role: primary

scalpel@snu.ac.kr

82-2-2072-3020

Suk Ho Sohn, MD

Role: backup

shsohn@snu.ac.kr

82-2-2072-1949

Other Identifiers

H-2211-023-1376

Identifier Type: -

Identifier Source: org_study_id