Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2025-12-17 @ 11:08 AM
Study NCT ID:
NCT04782492
Status:
None
Last Update Posted:
2024-04-19 00:00:00
First Post:
2021-03-02 00:00:00
Brief Title:
IVUS Study for SV Graft: Y-composite vs Aortocoronary Conduit
Sponsor:
Ho Young Hwang
Organization:
Seoul National University Hospital
Study Overview
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
Status:
None
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONFIG
Brief Summary:
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.
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.
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 eg 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 eg 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
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 eg 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None