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

NCT ID: NCT00318435

Last Updated: 2008-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Stent or stent-graft deployment

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center, Jerusalem , Israel

Principal Investigators

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David Shemesh, MD

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 18829240 (View on PubMed)

Other Identifiers

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2646

Identifier Type: -

Identifier Source: org_study_id