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

Rijnstate Hospital1 site in 1 country20 target enrollmentMarch 24, 2008

ConditionsOutflow Stenosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Outflow Stenosis
Sponsor: Rijnstate Hospital
Enrollment: 20
Locations: 1
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 24, 2008

End Date

August 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Rijnstate Hospital

Eligibility Criteria

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