Stenting of Haemodialysis Acces Trial

Phase 2

• Conditions: 10003216; outflow-stenosis; stentgraft; 10003184

• Registration Number: NL-OMON31017
• Lead Sponsor: W. L. Gore & Associates Inc, U.S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patient of 18 years of age
Patient has a life expectancy of at least 2 years
Patient has re- stenosis within 2 cm from the anastomosis of a loop arterio venous fistula
Signed informed consent

Exclusion Criteria

Patient unsuitable for administration of contrast agent
Dementio or atered mental status that would prohibit giving conscious informed consent
Need for adjunctive major surgical procedures within 1 month
Other stenosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br>Primary patency<br /><br>Secondary patency<br /><br>Graft failure</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br>Number of radiological re-interventions<br /><br>Number of Surgical interventions<br /><br>Graft infection</p><br>