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Stenting of Haemodialysis Acces Trial

Stenting of Haemodialysis Acces Trial - SHARE Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON31017
Enrollment
20
Registered
2008-05-20
Start date
2007-12-01
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

outflow-stenosis stentgraft

Interventions

In all patients an angioplasty will be performed with a high-pressure balloon, according to local protocols. If indicated, a cutting balloon may be used. After dilatation a 5 cm viabahn will be plac

Sponsors

W. L. Gore & Associates Inc, U.S.A.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Primary endpoints: Primary patency Secondary patency Graft failure

Secondary

MeasureTime frame
Secondary endpoints Number of radiological re-interventions Number of Surgical interventions Graft infection

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)