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Completed

NCT Number: NCT04782492

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Intima-media thickness (IMT)

    Time frame: at postoperative 1 year

    Intima-media thickness measured by intravascular ultrasound (IVUS)

Secondary outcomes

  1. Lumen diameter (LD)

    Time frame: at postoperative 1 year

    Lumen diameter measured by intravascular ultrasound (IVUS)

  2. Graft patency

    Time frame: at postoperative 1 year

    Graft patency measured by coronary angiography

  3. All cause mortality

    Time frame: at postoperative 1 year

    all deaths from any cause

  4. Cardiac death

    Time frame: at postoperative 1 year

    Any death related to cardiac events, including sudden death during follow-up

  5. Target vessel revascularization

    Time frame: at postoperative 1 year

    The number of patients who received any intervention performed for the previously bypassed target vessel during follow-up

  6. Reintervention

    Time frame: at postoperative 1 year

    The number of patients who received any coronary intervention performed during follow-up due to the coronary artery disease

Sponsors and collaborators

Lead sponsor

Ho Young Hwang

Other

Registry information

Official study title

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

Acronym: CONFIG

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2021
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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