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

Primary Purpose

Coronary Artery Disease, Morphologic Change

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
graft configuration in coronary artery bypass grafting
Sponsored by
Ho Young Hwang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Y-composite graft

aortocoronary conduit

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Intima-media thickness (IMT)
Intima-media thickness measured by intravascular ultrasound (IVUS)

Secondary Outcome Measures

Lumen diameter (LD)
Lumen diameter measured by intravascular ultrasound (IVUS)
Graft patency
Graft patency measured by coronary angiography
All cause mortality
all deaths from any cause
Cardiac death
Any death related to cardiac events, including sudden death during follow-up
Target vessel revascularization
The number of patients who received any intervention performed for the previously bypassed target vessel during follow-up
Reintervention
The number of patients who received any coronary intervention performed during follow-up due to the coronary artery disease

Full Information

First Posted
March 2, 2021
Last Updated
February 27, 2023
Sponsor
Ho Young Hwang
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1. Study Identification

Unique Protocol Identification Number
NCT04782492
Brief Title
IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit
Acronym
CONFIG
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ho Young Hwang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Morphologic Change
Keywords
Coronary artery bypass grafting, Saphenous vein, Intravascular ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Y-composite graft
Arm Type
Experimental
Arm Description
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.
Arm Title
aortocoronary conduit
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
graft configuration in coronary artery bypass grafting
Intervention Description
Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting
Primary Outcome Measure Information:
Title
Intima-media thickness (IMT)
Description
Intima-media thickness measured by intravascular ultrasound (IVUS)
Time Frame
at postoperative 1 year
Secondary Outcome Measure Information:
Title
Lumen diameter (LD)
Description
Lumen diameter measured by intravascular ultrasound (IVUS)
Time Frame
at postoperative 1 year
Title
Graft patency
Description
Graft patency measured by coronary angiography
Time Frame
at postoperative 1 year
Title
All cause mortality
Description
all deaths from any cause
Time Frame
at postoperative 1 year
Title
Cardiac death
Description
Any death related to cardiac events, including sudden death during follow-up
Time Frame
at postoperative 1 year
Title
Target vessel revascularization
Description
The number of patients who received any intervention performed for the previously bypassed target vessel during follow-up
Time Frame
at postoperative 1 year
Title
Reintervention
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Young Hwang, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared because it is not allowed by our Institutional Review Board.

Learn more about this trial

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

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