Stenting of Haemodialysis Acces Trial

Outflow Stenosis Clinical Trial

— SHARE  

Official title:

Stenting of Haemodialysis Acces Re-stenosis Trial (SHARE Trial)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642083
• Other study ID #: LTC-499-301107
• Status: Terminated
• Phase: Phase 2
• First received: March 19, 2008
• Last updated: December 14, 2011
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Outflow Stenosis

Intervention

Device:
• Viabahn 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.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	W.L.Gore & Associates

Country where clinical trial is conducted

Netherlands,