Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG

NCT05704296 | Recruiting

• 1 other identifier: H-2211-023-1376
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery bypass grafting; saphenous vein; coronary angiography

Outcome Measures

Primary Outcomes (1)

• Graft patency

  Graft patency measured by coronary angiography

  at postoperative 1 year

Secondary Outcomes (5)

• All-cause mortality

  at postoperative 1 year

• Cardiac death

  at postoperative 1 year

• Target vessel revascularization

  at postoperative 1 year

• Reintervention

  at postoperative 1 year

• Major Adverse Cardiac Events (MACEs)

  at postoperative 1 year

Study Arms (2)

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.

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.

Procedure: Aortocoronary grafting

Interventions

Y-composite grafting PROCEDURE

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

Y-composite grafting

Aortocoronary grafting PROCEDURE

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

Aortocoronary grafting

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ho Young Hwang: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ho Young Hwang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Young Hwang, MD, PhD

CONTACT

00-82-10-4004-3673; scalpel@snu.ac.kr

Suk Ho Sohn, MD

CONTACT

00-82-10-9114-3168; shsohn@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)