Safety and Efficacy of Angiotech Vascular Wrap Paclitaxel-Eluting Mesh for Hemodialysis Vascular Access

This study has been terminated.
(Due to an imbalance in graft infections between groups.)
Sponsor:
Information provided by (Responsible Party):
Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00448708
First received: March 15, 2007
Last updated: October 13, 2011
Last verified: October 2011
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Kidney Diseases
ESRD
Interventions: Device: Vascular Wrap Paclitaxel-Eluting Mesh
Device: Lifespan® ePTFE Vascular Graft

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Vascular Wrap and Graft Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
Lifespan® ePTFE Vascular Graft Lifespan® ePTFE Vascular Graft Only

Participant Flow:   Overall Study
    Vascular Wrap and Graft     Lifespan® ePTFE Vascular Graft  
STARTED     112     110  
COMPLETED     77     79  
NOT COMPLETED     35     31  
Death                 21                 17  
Withdrawal by Subject                 8                 4  
Lost to Follow-up                 6                 8  
not listed                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Vascular Wrap and Graft Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
Lifespan® ePTFE Vascular Graft Lifespan® ePTFE Vascular Graft Only
Total Total of all reporting groups

Baseline Measures
    Vascular Wrap and Graft     Lifespan® ePTFE Vascular Graft     Total  
Number of Participants  
[units: participants]
  112     110     222  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     54     62     116  
>=65 years     58     48     106  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 13.72     61  ± 15.58     63  ± 14.70  
Gender  
[units: participants]
     
Female     61     65     126  
Male     51     45     96  
Region of Enrollment  
[units: participants]
     
United States     112     110     222  



  Outcome Measures
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1.  Primary:   Time-to-loss of Target Site Primary Patency   [ Time Frame: 1 year ]

2.  Secondary:   Adverse Events   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to an observed imbalance in the number of graft infections, enrollment in the 1-year study 012-VWAV06 was suspended at the recommendation of the DSMC. Many of the planned efficacy analyses did not occur as a result of this suspension.  


Results Point of Contact:  
Name/Title: Dr. Trudy Estridge
Organization: Angiotech Pharmaceuticals
phone: 604-221-7676
e-mail: testridge@angio.com


No publications provided


Responsible Party: Angiotech Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00448708     History of Changes
Other Study ID Numbers: 012-VWAV06
Study First Received: March 15, 2007
Results First Received: June 8, 2011
Last Updated: October 13, 2011
Health Authority: United States: Food and Drug Administration