Stenting of Haemodialysis Acces Trial (SHARE)
December 14, 2011 updated by: Rijnstate Hospital
Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)
The purpose of this study is to demonstrate the efficacy of a PTFE covered stent-graft in the prevention of outflow re-stenosis in loop fistula in a prospective trial.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
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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Arnhem, Netherlands
- Rijnstate Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients of 18 years of age
- Patients have a life expectancy of at least 2 years
- Signed informed consent
- Recurrent stenosis at the venous anastomosis or in the draining vein of a loop arterio venous fistula, within 2 cm from the anastomosis.
Exclusion Criteria:
- Patient unsuitable for administration of contrast agent
- Pregnancy
- Dementia or altered mental status that would prohibit giving conscious informed consent
- Need for adjunctive major surgical or vascular procedures within one month
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: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
viabahn stent-graft
|
The viabahn stent-graft is a combined ePTFE-Nitinol self-expanding stent-graft preloaded on a catheter-based delivery system.
It was originally designed for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm.
This device is also increasingly used for the exclusion of popliteal aneurysms.
Its flexibility might make the device ideal for the treatment of recurrent outflow stenosis in AV loop-fistula.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
March 19, 2008
First Submitted That Met QC Criteria
March 19, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
December 15, 2011
Last Update Submitted That Met QC Criteria
December 14, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LTC-499-301107
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.