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

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ClinicalTrials.gov Identifier: NCT04782492
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : December 23, 2021
Sponsor:
Information provided by (Responsible Party):
Ho Young Hwang, Seoul National University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Morphologic Change Procedure: graft configuration in coronary artery bypass grafting Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: saphenous vein as Y-composite graft based on the left internal thoracic artery versus aortocoronary conduit
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 8, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
Saphenous vein could be used as Y-composite graft or aortocoronary conduit during 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
Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting


Outcome Measures
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Primary Outcome Measures :
  1. Intima-media thickness (IMT) [ Time Frame: at postoperative 1 year ]
    Intima-media thickness measured by intravascular ultrasound (IVUS)


Secondary Outcome Measures :
  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. Freedom from target vessel revascularization [ Time Frame: at postoperative 1 year ]
    Freedom from intervention performed for the previously bypassed target vessel during follow-up

  6. Freedom from reintervention [ Time Frame: at postoperative 1 year ]
    Freedom from any coronary intervention performed during follow-up due to the coronary artery disease


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782492


Contacts
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Contact: Ho Young Hwang, MD, PhD 00-82-10-4004-3673 scalpel@hanmail.net
Contact: Suk Ho Sohn, MD 00-82-10-9114-3168 xsshssx@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ho Young Hwang, MD, PhD    82-2-2072-3020    scalpel@hanmail.net   
Contact: Suk Ho Sohn, MD    82-2-2072-3897    xsshssx@gmail.com   
Sponsors and Collaborators
Ho Young Hwang
Investigators
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Principal Investigator: Ho Young Hwang, MD, PhD Seoul National University Hospital
More Information
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Responsible Party: Ho Young Hwang, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04782492    
Other Study ID Numbers: H-2101-143-1191
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared because it is not allowed by our Institutional Review Board.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ho Young Hwang, Seoul National University Hospital:
Coronary artery bypass grafting
Saphenous vein
Intravascular ultrasound
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases