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

February 7, 2013 updated by: Angiotech Pharmaceuticals

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93710
        • Ladenheim, Inc.
      • Inglewood, California, United States, 90301
        • Centinela Hospital
      • Los Angeles, California, United States, 90017
        • National Institute of Clinical Research
      • Los Angeles, California, United States, 90033
        • USC CVTI - Healthcare Consultation II
      • San Diego, California, United States, 92120
        • Southern California Permanente Medical Group
      • San Diego, California, United States, 92109
        • UCSD Medical Center
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center
    • Florida
      • Gainsville, Florida, United States, 32605
        • Florida Research Network, LLC
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clincal Research
      • Ocala, Florida, United States, 34471
        • Discovery Medical Research Group
      • Pensacola, Florida, United States, 32501
        • Baptist Hospital
      • Tampa, Florida, United States, 33606
        • University of South Florida- Research Foundation
    • Georgia
      • Macon, Georgia, United States, 31208
        • Cardiothoracic and Vascular Surgery Associates
    • Illinois
      • Peoria, Illinois, United States, 61603
        • Renal Care Associates
      • Springfield, Illinois, United States, 62702
        • Southern Illinois University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Washington County Hospital Association
    • Michigan
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Research Center
      • Lansing, Michigan, United States, 48910
        • Thoracic And Cardiovascular Healthcare Foundation
    • New York
      • Bronx, New York, United States, 10467
        • BRANY - Montefiore Medical Center
      • Flushing, New York, United States, 11355
        • Nephrology Associates P. C.
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt Hospital Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Rex Healthcare
      • Winston-Salem, North Carolina, United States, 27103
        • Clinical Research of Winston-Salem, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
      • Toledo, Ohio, United States, 43615
        • University of Toledo
    • Texas
      • Fort Worth, Texas, United States, 76135
        • Health First Medical Group
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center
      • San Antonio, Texas, United States, 78205
        • Peripheral Vascular Associates
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • The Wisconsin Heart Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Device: Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Other Names:
  • Vascular Wrap
PLACEBO_COMPARATOR: Graft
Lifespan® ePTFE Vascular Graft Only
Device: Lifespan® ePTFE Vascular Graft Only
Vascular Graft only

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiotech Pharmaceuticals

Investigators

  • Study Chair: Rui Avelar, M.D., Angiotech Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

December 15, 2009

First Submitted That Met QC Criteria

December 15, 2009

First Posted (ESTIMATE)

December 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014-VWAV07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hyperplasia

Clinical Trials on Graft, Vascular Wrap

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe