Outflow Stenosis
Conditions
Keywords
outflow stenosis, stentgraft
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.
Interventions
DEVICEViabahn 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.
Sponsors
W.L.Gore & Associates
Rijnstate Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
Netherlands
Outcome results
None listed