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Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG (CONFIG2)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Y-composite grafting
Aortocoronary 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, coronary angiography

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 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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Y-composite grafting

Aortocoronary grafting

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

Graft patency
Graft patency measured by coronary angiography

Secondary Outcome Measures

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
Intervention performed for the previously bypassed target vessel during follow-up
Reintervention
Any coronary intervention performed during follow-up due to the coronary artery disease
Major Adverse Cardiac Events (MACEs)
acute myocardial infarction, coronary reintervention, and cardiac death including sudden death during follow-up

Full Information

First Posted
January 20, 2023
Last Updated
July 8, 2023
Sponsor
Ho Young Hwang
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1. Study Identification

Unique Protocol Identification Number
NCT05704296
Brief Title
Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG
Acronym
CONFIG2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
January 31, 2028 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery bypass grafting, saphenous vein, coronary angiography

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
290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Y-composite grafting
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 grafting
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)
Y-composite grafting
Intervention Description
Saphenous vein is used as a Y-composite graft during coronary artery bypass grafting
Intervention Type
Procedure
Intervention Name(s)
Aortocoronary grafting
Intervention Description
Saphenous vein is used as an aortocoronary graft during coronary artery bypass grafting
Primary Outcome Measure Information:
Title
Graft patency
Description
Graft patency measured by coronary angiography
Time Frame
at postoperative 1 year
Secondary Outcome Measure Information:
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
Intervention performed for the previously bypassed target vessel during follow-up
Time Frame
at postoperative 1 year
Title
Reintervention
Description
Any coronary intervention performed during follow-up due to the coronary artery disease
Time Frame
at postoperative 1 year
Title
Major Adverse Cardiac Events (MACEs)
Description
acute myocardial infarction, coronary reintervention, and cardiac death including sudden death during follow-up
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ho Young Hwang, MD, PhD
Phone
00-82-10-4004-3673
Email
scalpel@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Suk Ho Sohn, MD
Phone
00-82-10-9114-3168
Email
shsohn@snu.ac.kr
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Young Hwang, MD, PhD
Phone
82-2-2072-3020
Email
scalpel@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Suk Ho Sohn, MD
Phone
82-2-2072-1949
Email
shsohn@snu.ac.kr

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.

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Saphenous Vein as Y-composite Versus Aortocoronary Conduit for CABG

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