Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761068
Status:
RECRUITING
Last Update Posted:
2021-02-18
First Post:
2021-02-16
Brief Title:
Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
Sponsor:
Cardiocentro Ticino
Organization:
Cardiocentro Ticino
Study Overview
Official Title:
Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting CABG Surgery With VEST Supported Venous Grafts
Status:
RECRUITING
Status Verified Date:
2021-02
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:
This is a prospective investigator-initiated multi-center open label and post-market registry enrolling patients with atherosclerotic coronary artery disease scheduled for CABG with at least one SVG bypass
The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device VEST for SVG bypasses
In each patient use of the VEST will be according to its approved indications for use and attempt will be made based on clinical judgement to support each non-sequential SVG bypass graft with a VEST device
Subjects will be followed for 5 years with interim follow ups at 12 and 24 months
MACCE and EQ5D3L will be documented at every follow up visit
The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device VEST for SVG bypasses
In each patient use of the VEST will be according to its approved indications for use and attempt will be made based on clinical judgement to support each non-sequential SVG bypass graft with a VEST device
Subjects will be followed for 5 years with interim follow ups at 12 and 24 months
MACCE and EQ5D3L will be documented at every follow up visit
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