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Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05704296
Acronym
CONFIG2
Enrollment
290
Registered
2023-01-30
Start date
2023-04-18
Completion date
2028-01-31
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

coronary artery bypass grafting, saphenous vein, coronary angiography

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.

Interventions

PROCEDUREY-composite grafting

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

PROCEDUREAortocoronary grafting

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

Sponsors

Ho Young Hwang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Graft patencyat postoperative 1 yearGraft patency measured by coronary angiography

Secondary

MeasureTime frameDescription
All-cause mortalityat postoperative 1 yearall deaths from any cause
Cardiac deathat postoperative 1 yearAny death related to cardiac events, including sudden death during follow-up
Target vessel revascularizationat postoperative 1 yearIntervention performed for the previously bypassed target vessel during follow-up
Reinterventionat postoperative 1 yearAny coronary intervention performed during follow-up due to the coronary artery disease
Major Adverse Cardiac Events (MACEs)at postoperative 1 yearacute myocardial infarction, coronary reintervention, and cardiac death including sudden death during follow-up

Countries

South Korea

Contacts

CONTACTHo Young Hwang, MD, PhD
scalpel@snu.ac.kr00-82-10-4004-3673
CONTACTSuk Ho Sohn, MD
shsohn@snu.ac.kr00-82-10-9114-3168
PRINCIPAL_INVESTIGATORHo Young Hwang, MD, PhD

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026