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Bard® LifeStent® Vascular Stent Delivery System Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01179984
First Posted: August 11, 2010
Last Update Posted: March 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
C. R. Bard
Results First Submitted: November 9, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Peripheral Vascular Disease
Intervention: Device: Bard® LifeStent® Vascular Stent System

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
PTA and Study Stent The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.

Participant Flow:   Overall Study
    PTA and Study Stent
STARTED   76 
COMPLETED   58 
NOT COMPLETED   18 



  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.
The baseline analysis population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.

Reporting Groups
  Description
Single-Arm The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.

Baseline Measures
   Single-Arm 
Overall Participants Analyzed 
[Units: Participants]
 76 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      24  31.6% 
>=65 years      52  68.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.1  (8.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      25  32.9% 
Male      51  67.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      76 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      76 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
Austria   0 
Germany   76 


  Outcome Measures
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1.  Primary:   Acute Effectiveness: Percentage of Stents With Successful Delivery   [ Time Frame: At implantation (Day 0) ]

2.  Primary:   (Safety) Freedom From Occurrence of Death, Amputation and TVR/TLR at 30-days Post-index Procedure.   [ Time Frame: 30 day follow-up ]

3.  Secondary:   Primary Target Lesion Patency   [ Time Frame: 12 months post-index procedure ]


  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
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  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: Associate Director of Clinical Affairs
Organization: Bard Peripheral Vascular
phone: 480-379-2838
e-mail: josh.smale@crbard.com



Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01179984     History of Changes
Other Study ID Numbers: BPV-09-006
First Submitted: May 21, 2010
First Posted: August 11, 2010
Results First Submitted: November 9, 2016
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017