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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 
Overall Participants Analyzed 
[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


  Limitations and Caveats
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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.


  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.


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



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