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

Primary Purpose

End Stage Renal Failure on Dialysis, Hyperplasia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Graft, Vascular Wrap
Lifespan® ePTFE Vascular Graft Only
Sponsored by
Angiotech Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Failure on Dialysis focused on measuring dialysis, hemodialysis, neointimal hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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  • Subjects who withdrew or were withdrawn from study 012-VWAV06.

Sites / Locations

  • Ladenheim, Inc.
  • Centinela Hospital
  • National Institute of Clinical Research
  • USC CVTI - Healthcare Consultation II
  • UCSD Medical Center
  • Southern California Permanente Medical Group
  • San Francisco VA Medical Center
  • Florida Research Network, LLC
  • Jacksonville Center for Clincal Research
  • Discovery Medical Research Group
  • Baptist Hospital
  • University of South Florida- Research Foundation
  • Cardiothoracic and Vascular Surgery Associates
  • Renal Care Associates
  • Southern Illinois University
  • Indiana University
  • Washington County Hospital Association
  • Michigan Vascular Research Center
  • Thoracic and Cardiovascular Healthcare Foundation
  • BRANY - Montefiore Medical Center
  • Nephrology Associates P. C.
  • St. Luke's Roosevelt Hospital Center
  • Rex Healthcare
  • Clinical Research of Winston-Salem, Inc.
  • University of Cincinnati Medical Center
  • University of Toledo
  • Health First Medical Group
  • Texas Tech University Health Sciences Center
  • Peripheral Vascular Associates
  • The Wisconsin Heart Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Graft, Vascular Wrap

Graft

Arm Description

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

Lifespan® ePTFE Vascular Graft Only

Outcomes

Primary Outcome Measures

Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events

Secondary Outcome Measures

Full Information

First Posted
December 15, 2009
Last Updated
February 7, 2013
Sponsor
Angiotech Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01033357
Brief Title
Safety Study of the Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Imbalance in the # graft infections between the tx's (graft vs. graft + wrap)
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Angiotech Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Failure on Dialysis, Hyperplasia
Keywords
dialysis, hemodialysis, neointimal hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
222 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Graft, Vascular Wrap
Arm Type
Active Comparator
Arm Description
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Arm Title
Graft
Arm Type
Placebo Comparator
Arm Description
Lifespan® ePTFE Vascular Graft Only
Intervention Type
Device
Intervention Name(s)
Graft, Vascular Wrap
Other Intervention Name(s)
Vascular Wrap
Intervention Description
Lifespan® ePTFE Vascular Graft and Vascular Wrap Paclitaxel-Eluting Mesh (0.9 µg/mm2 paclitaxel)
Intervention Type
Device
Intervention Name(s)
Lifespan® ePTFE Vascular Graft Only
Intervention Description
Vascular Graft only
Primary Outcome Measure Information:
Title
Nature and incidence of Adverse Events between treatment groups clinical difference in product-related adverse events
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Avelar, M.D.
Organizational Affiliation
Angiotech Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Ladenheim, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Centinela Hospital
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
National Institute of Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
USC CVTI - Healthcare Consultation II
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCSD Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92109
Country
United States
Facility Name
Southern California Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Jacksonville Center for Clincal Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Discovery Medical Research Group
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
University of South Florida- Research Foundation
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cardiothoracic and Vascular Surgery Associates
City
Macon
State/Province
Georgia
ZIP/Postal Code
31208
Country
United States
Facility Name
Renal Care Associates
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington County Hospital Association
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Michigan Vascular Research Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48507
Country
United States
Facility Name
Thoracic and Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
BRANY - Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Nephrology Associates P. C.
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Rex Healthcare
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Clinical Research of Winston-Salem, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Toledo
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43615
Country
United States
Facility Name
Health First Medical Group
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Peripheral Vascular Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
The Wisconsin Heart Hospital
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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

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