Coronary Artery Disease Clinical Trial
— CONFIG2Official 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
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.
Status | Recruiting |
Enrollment | 290 |
Est. completion date | January 31, 2028 |
Est. primary completion date | January 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Ho Young Hwang |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Graft patency | Graft patency measured by coronary angiography | at postoperative 1 year | |
Secondary | All-cause mortality | all deaths from any cause | at postoperative 1 year | |
Secondary | Cardiac death | Any death related to cardiac events, including sudden death during follow-up | at postoperative 1 year | |
Secondary | Target vessel revascularization | Intervention performed for the previously bypassed target vessel during follow-up | at postoperative 1 year | |
Secondary | Reintervention | Any coronary intervention performed during follow-up due to the coronary artery disease | at postoperative 1 year | |
Secondary | Major Adverse Cardiac Events (MACEs) | acute myocardial infarction, coronary reintervention, and cardiac death including sudden death during follow-up | at postoperative 1 year |
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