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

NCT04782492 | Completed

• 1 other identifier: H-2101-143-1191
• Study Type: interventional
• Target: 50
• 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; Morphologic Change

Keywords

Coronary artery bypass grafting; Saphenous vein; Intravascular ultrasound

Outcome Measures

Primary Outcomes (1)

• Intima-media thickness (IMT)

  Intima-media thickness measured by intravascular ultrasound (IVUS)

  at postoperative 1 year

Secondary Outcomes (6)

• Lumen diameter (LD)

  at postoperative 1 year

• Graft patency

  at postoperative 1 year

• All cause mortality

  at postoperative 1 year

• Cardiac death

  at postoperative 1 year

• Target vessel revascularization

  at postoperative 1 year

Study Arms (2)

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.

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.

Procedure: graft configuration in coronary artery bypass grafting

Interventions

graft configuration in coronary artery bypass grafting PROCEDURE

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

Y-composite graft; aortocoronary conduit

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

Sponsors & Collaborators

• Ho Young Hwang: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 40338976 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Ho Young Hwang, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

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: March 2, 2021
• First Posted: March 4, 2021
• Study Start: July 8, 2021
• Primary Completion: September 27, 2023
• Study Completion: September 27, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)