Back to resultsStenting of Haemodialysis Acces Trial (SHARE)
Primary Purpose
Outflow Stenosis
Status
Terminated
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Viabahn stent-graft
Sponsored by
About this trial
This is an interventional treatment trial for Outflow Stenosis focused on measuring outflow stenosis, stentgraft
Eligibility Criteria
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
Sites / Locations
- Rijnstate Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
viabahn stent-graft
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00642083
First Posted
March 19, 2008
Last Updated
December 14, 2011
Sponsor
Rijnstate Hospital
Collaborators
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT00642083
Brief Title
Stenting of Haemodialysis Acces Trial
Acronym
SHARE
Official Title
Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Terminated
Why Stopped
slow inclusion
Study Start Date
undefined (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rijnstate Hospital
Collaborators
W.L.Gore & Associates
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Outflow Stenosis
Keywords
outflow stenosis, stentgraft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
viabahn stent-graft
Intervention Type
Device
Intervention Name(s)
Viabahn stent-graft
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Stenting of Haemodialysis Acces Trial
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