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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01305564
First received: January 31, 2011
Last updated: February 29, 2016
Last verified: February 2016
Results First Received: November 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Embolism
Intervention: Device: Denali inferior vena cava filter

  Participant Flow
  Hide Participant Flow

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
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  
COMPLETED     163  
NOT COMPLETED     37  
Death                 21  
Lost to Follow-up                 12  
Withdrawal by Subject                 1  
Physician Decision                 3  



  Baseline Characteristics
  Hide 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
  Description
Baseline Characteristics All treated with Denali filter.

Baseline Measures
    Baseline Characteristics  
Number of Participants  
[units: participants]
  200  
Age  
[units: years]
Mean (Standard Deviation)
  56.6  (15.63)  
Gender  
[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
  Show All 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
  Hide 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
No text entered.


  More Information
  Hide 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
e-mail: ryan.melloy@crbard.com



Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01305564     History of Changes
Other Study ID Numbers: BPV-09-007
Study First Received: January 31, 2011
Results First Received: November 3, 2015
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration