Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318435
Status:
COMPLETED
Last Update Posted:
2008-08-19
First Post:
2006-04-25
Brief Title:
Fluency Stent-Graft Versus Luminex Stent for Angioplasty of Recurrent Stenosis of the Cephalic Arch in Autogenous Arteriovenous AV Access for Hemodialysis
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-04
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:
The type of hemodialysis access and preservation of this access greatly influences the quality of life and survival of patients undergoing hemodialysis The Kidney Disease Outcomes Quality Initiative KDOQI guidelines for vascular access recommend the primary placement of native or autogenous hemodialysis fistulas in preference to polytetrafluoroethylene PTFE grafts and central venous catheters because the former form of access has fewer complications and a longer durability However autogenous hemodialysis fistulas like polytetrafluoroethylene grafts are also subject to dysfunction and eventual failure Endovascular angioplasty has become an accepted alternative treatment to surgical revision for hemodialysis access-related venous stenoses and occlusions However the patency rates in the follow-up period are low because of the high frequency of restenosis due to intimal hyperplasia Since 1988 noncovered stents have been used to improve fistula patency In the central veins bare stents demonstrate better patency rates than percutaneous transluminal angioplasty PTA alone Neointimal hyperplasia is the major reason for restenosis following stent placement The cephalic vein forms the outflow conduit for radiocephalic and brachiocephalic autogenous fistulas It has recently been suggested that a focal area of the cephalic vein is prone to developing hemodynamically significant stenosis in what is now termed the cephalic arch This is the perpendicular portion of the cephalic vein in the region of the deltopectoral groove before its junction with the axillary vein To overcome the problem of restenosis due to intimal hyperplasia in the cephalic arch the investigators used the insertion of a stent-graft as an alternative approach In this study they investigated the use of a PTFE-covered nitinol stent-graft Fluency Bard versus a Luminex Bard stent
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None