TerminatedNot Applicable

Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

Stopped: Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)

United States222 participantsStarted 2008-03

Plain-language summary

The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: To be considered for enrollment, subjects must: * have been randomized in protocol 012-VWAV06; * have signed and dated an IRB-approved written informed consent to participate in 012-VWAV06 as well as this study; * be willing to comply with all aspects of the evaluation schedule over a period of 60 months post device insertion; * allow representatives of the sponsor, designated Clinical Research Organization (CRO), Institutional Review Board (IRB), the Ethics Committee, and U.S. Food and Drug Administration (FDA) to review his/her relevant medical records. Exclusion Criteria: * Subjects who withdrew or were withdrawn from study 012-VWAV06.

What they're measuring

Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events

Timeframe: 4 years

Trial details

NCT IDNCT01033357

SponsorAngiotech Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

View on ClinicalTrials.gov More End Stage Renal Failure on Dialysis trials