Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500897
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
VEST Device to Enhance Safein Vein Patency
Sponsor:
Cardiochirurgia EH
Organization:
Cardiochirurgia EH
Study Overview
Official Title:
Mid Term Follow up of VEST Device to Enhance Safein Vein Patency a Multicentric Study
Status:
COMPLETED
Status Verified Date:
2024-07
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:
None
Brief Summary:
Purpose - Bypass grafting is the gold standard for severe coronary disease yet most repeat revascularizations target previously grafted territories External stenting of saphenous vein grafts the most frequently used bypass conduit has been shown to minimize disease markers This study evaluates clinical outcomes of external stenting in real world routine practice
Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial andor venous grafts One or more venous grafts were externally stented Choice of conduits use of cardiopulmonary bypass and vein harvesting technique were performed according to the routine practice of each surgeon
All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects
Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial andor venous grafts One or more venous grafts were externally stented Choice of conduits use of cardiopulmonary bypass and vein harvesting technique were performed according to the routine practice of each surgeon
All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects
Detailed Description:
None
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