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

Not Applicable

Terminated

• Conditions: End Stage Renal Failure on Dialysis; Hyperplasia

• Registration Number: NCT01033357
• Lead Sponsor: Angiotech Pharmaceuticals

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 Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-12-15
• Study First Submitted QC: 2009-12-15
• Study First Posted: 2009-12-16
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-07
• Disposition First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Disposition First Posted: 2013-02-11
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 222

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• Subjects who withdrew or were withdrawn from study 012-VWAV06.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (30)

Ladenheim, Inc.; 🇺🇸 Fresno, California, United States

Centinela Hospital; 🇺🇸 Inglewood, California, United States

National Institute of Clinical Research; 🇺🇸 Los Angeles, California, United States

USC CVTI - Healthcare Consultation II; 🇺🇸 Los Angeles, California, United States

UCSD Medical Center; 🇺🇸 San Diego, California, United States

Southern California Permanente Medical Group; 🇺🇸 San Diego, California, United States

San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Florida Research Network, LLC; 🇺🇸 Gainsville, Florida, United States

Jacksonville Center for Clincal Research; 🇺🇸 Jacksonville, Florida, United States

Discovery Medical Research Group; 🇺🇸 Ocala, Florida, United States

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