Stenting of Haemodialysis Acces Trial

Phase 2TerminatedNCT00642083

Rijnstate Hospital20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Enrollment

Conditions

Outflow Stenosis

Interventions

Viabahn stent-graftDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rijnstate Hospital

Arnhem, Netherlands

Data from ClinicalTrials.gov

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