Fluency Stent-Graft Versus Luminex Stent for Angioplasty of Recurrent Stenosis of the Cephalic Arch in Autogenous Arteriovenous (AV) Access for Hemodialysis

Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318435
• Other study ID #: 2646
• Status: Completed
• Phase: Phase 4
• First received: April 25, 2006
• Last updated: August 17, 2008
• Start date: May 2006
• Est. completion date: August 2006

Study information

• Verified date: April 2006
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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 (K/DOQI) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients included in this study would be presented for intervention after observation in the Vascular Access Unit for one of the following:

• the recurrent cephalic arch stenosis identified on periodic duplex scanning, performed by one of the surgeons from the Vascular Access Unit;

• reduction of flow rate of more than 20% from baseline access flow rate;

• dynamic venous pressures exceeded threshold levels three consecutive times; or

• clinical signs (arm swelling, pulsatile fistula, prolonged bleeding from puncture sites) suggesting fistula dysfunction in a patient with previously treated cephalic arch stenosis.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stenosis

Intervention

Device:
• Stent or stent-graft deployment

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel,