Stenting of Haemodialysis Acces Trial (SHARE)

Rijnstate Hospital

Status and phase: Terminated; Phase 2

Conditions: Outflow Stenosis

Treatments: Device: Viabahn stent-graft

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00642083

LTC-499-301107

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

1

Experimental group

Description:

viabahn stent-graft

Treatment:

Device: Viabahn stent-graft