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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
222

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angiotech Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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