A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System

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. Identifier: NCT01305564
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : December 7, 2015
Last Update Posted : March 30, 2016
Information provided by (Responsible Party):
C. R. Bard

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pulmonary Embolism
Intervention: Device: Denali inferior vena cava filter

  Participant Flow

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
Denali Inferior Vena Cava Filter

All subjects enrolled will receive the Denali vena cava filter.

Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube.

Participant Flow:   Overall Study
    Denali Inferior Vena Cava Filter
STARTED   200 
Death                21 
Lost to Follow-up                12 
Withdrawal by Subject                1 
Physician Decision                3 

  Baseline Characteristics

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.
All subjects receiving a Denali vena cava filter.

Reporting Groups
Baseline Characteristics All treated with Denali filter.

Baseline Measures
   Baseline Characteristics 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Standard Deviation)
 56.6  (15.63) 
[Units: Participants]
Female   74 
Male   126 
Ethnicity (NIH/OMB) 
[Units: Participants]
Hispanic or Latino   11 
Not Hispanic or Latino   189 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participants]
American Indian or Alaska Native   1 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   31 
White   164 
More than one race   0 
Unknown or Not Reported   4 
Region of Enrollment 
[Units: Participants]
United States   200 

  Outcome Measures

1.  Primary:   Technical Success of Placement   [ Time Frame: 6 months ]

2.  Primary:   Clinical Success of Placement   [ Time Frame: 6 months ]

3.  Primary:   Technical Success of Retrieval   [ Time Frame: 24 months ]

4.  Primary:   Clinical Success of Retrieval   [ Time Frame: 24 months ]

5.  Secondary:   Rate of Recurring Pulmonary Embolism   [ Time Frame: 24 months ]

6.  Secondary:   Rate of New or Worsening Deep Vein Thrombosis   [ Time Frame: 6 months ]

7.  Secondary:   Filter Fracture   [ Time Frame: 6 months ]

8.  Secondary:   Filter Migration   [ Time Frame: 6 months ]

9.  Secondary:   Filter Tilt at Placement   [ Time Frame: Post-placement imaging ]

10.  Secondary:   Filter Tilt at Retrieval   [ Time Frame: Pre-retrieval imaging ]

11.  Secondary:   Filter Penetration >3mm at Placement   [ Time Frame: Post-placement ]

12.  Secondary:   Filter Penetration >3mm at Retrieval   [ Time Frame: Pre-retrieval ]

  Serious Adverse Events

  Other Adverse Events

  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
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  More Information

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: Ryan Melloy
Organization: Bard Peripheral Vascular
phone: 480-350-6074

Responsible Party: C. R. Bard Identifier: NCT01305564     History of Changes
Other Study ID Numbers: BPV-09-007
First Submitted: January 31, 2011
First Posted: February 28, 2011
Results First Submitted: November 3, 2015
Results First Posted: December 7, 2015
Last Update Posted: March 30, 2016