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

Morphologic Changes of 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
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04782492
Acronym
CONFIG
Enrollment
50
Registered
2021-03-04
Start date
2021-07-08
Completion date
2023-09-27
Last updated
2024-04-19

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

Conditions

Coronary Artery Disease, Morphologic Change

Keywords

Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound

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.

Interventions

PROCEDUREgraft configuration in coronary artery bypass grafting

Saphenous vein could be used as Y-composite graft or aortocoronary conduit 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

Design outcomes

Primary

MeasureTime frameDescription
Intima-media thickness (IMT)at postoperative 1 yearIntima-media thickness measured by intravascular ultrasound (IVUS)

Secondary

MeasureTime frameDescription
Graft patencyat postoperative 1 yearGraft patency measured by coronary angiography
All cause mortalityat postoperative 1 yearall deaths from any cause
Lumen diameter (LD)at postoperative 1 yearLumen diameter measured by intravascular ultrasound (IVUS)
Target vessel revascularizationat postoperative 1 yearThe number of patients who received any intervention performed for the previously bypassed target vessel during follow-up
Reinterventionat postoperative 1 yearThe number of patients who received any coronary intervention performed during follow-up due to the coronary artery disease
Cardiac deathat postoperative 1 yearAny death related to cardiac events, including sudden death during follow-up

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026