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Clinical Trials/NCT01033357
NCT01033357TerminatedNot Applicable

A Long Term Safety Study of the Vascular Wrap(TM) Paclitaxel-Eluting Mesh After Surgical Implantation With the Lifespan® Graft in the Upper Extremity for Hemodialysis Vascular Access

Angiotech Pharmaceuticals59 sites in 1 country222 target enrollmentStarted: March 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
222
Locations
59
Primary Endpoint
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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).

Detailed Description

The primary objective of this study is to determine long term safety of the Lifespan® ePTFE Vascular Graft and Vascular Wrap(TM) Paclitaxel-Eluting Mesh in comparison to the Lifespan® graft alone.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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  • •Subjects who withdrew or were withdrawn from study 012-VWAV06.

Outcomes

Primary Outcomes

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

Time Frame: 4 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Angiotech Pharmaceuticals
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (59)

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