Status:
TERMINATED
Stenting of Haemodialysis Acces Trial
Lead Sponsor:
Rijnstate Hospital
Collaborating Sponsors:
W.L.Gore & Associates
Conditions:
Outflow Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00642083
End Date
August 1 2011
Last Update
December 15 2011
Active Locations (1)
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1
Rijnstate Hospital
Arnhem, Netherlands