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

A

Angiotech Pharmaceuticals

Status

Terminated

Conditions

Hyperplasia
End Stage Renal Failure on Dialysis

Treatments

Device: Lifespan® ePTFE Vascular Graft Only
Device: Graft, Vascular Wrap

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033357
014-VWAV07

Details and patient eligibility

About

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).

Full 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.

Enrollment

222 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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 Exclusion Criteria: * Subjects who withdrew or were withdrawn from study 012-VWAV06.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

222 participants in 2 patient groups, including a placebo group

Graft, Vascular Wrap
Active Comparator group
Description:
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Treatment:
Device: Graft, Vascular Wrap
Graft
Placebo Comparator group
Description:
Lifespan® ePTFE Vascular Graft Only
Treatment:
Device: Lifespan® ePTFE Vascular Graft Only

Trial contacts and locations

30

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems