- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318435
Fluency Stent-Graft Versus Luminex Stent for Angioplasty of Recurrent Stenosis of the Cephalic Arch in Autogenous Arteriovenous (AV) Access for Hemodialysis
August 17, 2008 updated by: Shaare Zedek Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jerusalem, Israel
- Shaare Zedek Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Shemesh, MD, Shaare Zedek Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Completion (ACTUAL)
August 1, 2006
Study Registration Dates
First Submitted
April 25, 2006
First Submitted That Met QC Criteria
April 25, 2006
First Posted (ESTIMATE)
April 26, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
August 19, 2008
Last Update Submitted That Met QC Criteria
August 17, 2008
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2646
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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