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

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• Subjects who withdrew or were withdrawn from study 012-VWAV06.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

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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