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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01033357

Enrollment

222

Registered

2009-12-16

Start date

2008-03-31

Completion date

2010-10-31

Last updated

2013-02-11

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

Conditions

End Stage Renal Failure on Dialysis, Hyperplasia

Keywords

dialysis, hemodialysis, neointimal hyperplasia

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.

Interventions

DEVICEGraft, Vascular Wrap

Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)

DEVICELifespan® ePTFE Vascular Graft Only

Vascular Graft only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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* Subjects who withdrew or were withdrawn from study 012-VWAV06.

Design outcomes

Primary

Measure	Time frame
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events	4 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026