Stenting of Haemodialysis Acces Trial

Phase 2

Terminated

• Conditions: Outflow Stenosis
• Interventions: Device: Viabahn stent-graft

• Registration Number: NCT00642083
• Lead Sponsor: Rijnstate Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-24
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-14
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Viabahn stent-graft	viabahn stent-graft

Trial Locations

Locations (1)

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands