NCT00318435

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

August 19, 2008

Status Verified

April 1, 2006

First QC Date

April 25, 2006

Last Update Submit

August 17, 2008

Conditions

Stenosis

Interventions

Stent or stent-graft deploymentDEVICE

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Related Publications (1)

  • Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.

    PMID: 18829240DERIVED

MeSH Terms

Conditions

Constriction, Pathologic

Interventions

Stents

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • David Shemesh, MD

    Shaare Zedek Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2006

First Posted

April 26, 2006

Study Start

May 1, 2006

Study Completion

August 1, 2006

Last Updated

August 19, 2008

Record last verified: 2006-04

Locations

IL(1)