Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-31 @ 11:17 PM
Study NCT ID:
NCT00451256
Status:
TERMINATED
Last Update Posted:
2009-07-08
First Post:
2007-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)
Sponsor:
Sarepta Therapeutics, Inc.
Organization:
Study Overview
Official Title:
Clinical Study to Assess the Safety and Efficacy of ex-Vivo Vein Graft Exposure to AVI-5126 in Coronary Artery By-Pass Grafting to Reduce Clinical Graft Failure
Status:
TERMINATED
Status Verified Date:
2009-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Protocol-defined outcome in terms of efficacy would not be achieved.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
For some people who have heart by-pass surgery, the vein that is used to by-pass a blockage will, after some time, become narrowed and possibly blocked. AVI-5126 blocks a gene that is believed to be responsible for the events in the blood vessel that cause this narrowing. Therefore, exposing the vein to AVI-5126 before it is attached to the coronary artery may result in less problems with these vein grafts later on. This study will determine if this procedure is both safe and effective.
Detailed Description:
Coronary artery bypass (CABG) is a common procedure employed for life-threatening cardiovascular disease. While bypass surgery is effective in restoring blood flow in the short-term, 30 to 50 percent of venous bypass grafts eventually become blocked or fail. Within the first year after a CABG procedure, it is estimated that between 15 and 30% of saphenous vein grafts fail (i.e., ≥ 75% reduction in flow within the graft), due to intimal hyperplasia at the anastomosis sites. There is currently no approved treatment to prevent venous graft failure. These patients may frequently undergo a second bypass surgery if the extent of graft failure(s) is sufficiently severe to lead to uncontrolled angina pectoris. It is clear that a second CABG procedure in a patient represents a higher operative mortality rate than the first procedure. Venous graft failure in CABG is a major unmet medical-surgical problem.
AVI has previously focused some of its Neugene® products in the area of preventing cardiovascular stenosis. This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury. The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug (AVI-5126) solution will prevent subsequent graft failure at 1 year, compared to physiological saline (placebo) prior to graft anastomosis.
AVI has previously focused some of its Neugene® products in the area of preventing cardiovascular stenosis. This application of antisense targeted to to inhibit the c-myc gene has previously been demonstrated to prevent sequelae of intimal hyperplasia following endovascular injury. The purpose of this study is to evaluate whether immersion of the excised saphenous vein in a novel anti-c-myc antisense drug (AVI-5126) solution will prevent subsequent graft failure at 1 year, compared to physiological saline (placebo) prior to graft anastomosis.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: