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CompletedNCT04782492CONFIGUpdated Apr 19, 2024

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

An interventional study of graft configuration in coronary artery bypass grafting in Coronary Artery Disease and Morphologic Change, sponsored by Ho Young Hwang. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-19.

Sponsored by Ho Young Hwang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Morphologic Change

Keywords

  • Coronary artery bypass grafting
  • Saphenous vein
  • Intravascular ultrasound
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 50 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Ho Young Hwang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Y-composite graft

    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

  • Active comparator
    aortocoronary conduit

    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

  • Proceduregraft configuration in coronary artery bypass grafting

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

06

What researchers measure

Primary outcomes

  1. Intima-media thickness (IMT)

    Intima-media thickness measured by intravascular ultrasound (IVUS)

    Time frame: at postoperative 1 year

Secondary outcomes

  1. Lumen diameter (LD)

    Lumen diameter measured by intravascular ultrasound (IVUS)

    Time frame: at postoperative 1 year

  2. Graft patency

    Graft patency measured by coronary angiography

    Time frame: at postoperative 1 year

  3. All cause mortality

    all deaths from any cause

    Time frame: at postoperative 1 year

  4. Cardiac death

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

    Time frame: at postoperative 1 year

  5. Target vessel revascularization

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

    Time frame: at postoperative 1 year

  6. Reintervention

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

    Time frame: at postoperative 1 year

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because it is not allowed by our Institutional Review Board.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04782492
Lead sponsor
Ho Young Hwang
Responsible party
Ho Young Hwang (Professor, Seoul National University Hospital) — Sponsor-investigator
First posted
Mar 4, 2021
Start date
Jul 8, 2021
Primary completion
Sep 27, 2023
Completion
Sep 27, 2023
Last update
Apr 19, 2024

Study contacts

Ho Young Hwang, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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