Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-31 @ 6:26 PM
Study NCT ID:
NCT06434935
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-10
First Post:
2024-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Sponsor:
Vascudyne, Inc.
Organization:
Study Overview
Official Title:
Initial Evaluation of Vascudyne Coronary Artery Bypass Conduit
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
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:
False
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?: