Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434935
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-11
First Post:
2024-05-23
Brief Title:
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Sponsor:
Vascudyne Inc
Organization:
Vascudyne Inc
Study Overview
Official Title:
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
VCAB-1
Brief Summary:
The Vascudyne Coronary Artery Bypass Study VCAB-1 is an initial safety and feasibility study of the Vascudyne Inc Coronary Artery Bypass Conduit CAB A for bypass of stenosed native coronary arteries in patients undergoing coronary artery bypass surgery
Detailed Description:
Prospective non-randomized initial evaluation clinical study to assess the feasibility of TRUE CAB for secondary coronary targets in patients needing multiple coronary artery bypass
Patients will be implanted with a single TRUE CAB bypass single proximal and distal anastomoses to the second or third coronary arteries CA bypass target
The primary target CA shall be bypassed using an arterial graft The left anterior descending LAD CA bypass if needed shall be bypassed using the left internal mammary artery LIMA A saphenous vein shall be used for any additional targets as needed
Estimated enrollment for first three patients 2 weeks followed by enrollment over 4 months Follow up through 24 months
Patients will be implanted with a single TRUE CAB bypass single proximal and distal anastomoses to the second or third coronary arteries CA bypass target
The primary target CA shall be bypassed using an arterial graft The left anterior descending LAD CA bypass if needed shall be bypassed using the left internal mammary artery LIMA A saphenous vein shall be used for any additional targets as needed
Estimated enrollment for first three patients 2 weeks followed by enrollment over 4 months Follow up through 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None