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

Brief Summary:
The Bard® Denali™ Retrievable Inferior Vena Cava (IVC) study is a prospective, multi-center study which is intended to provide evidence of safety of the placement and retrieval of the Bard® Denali™ Retrievable Inferior Vena Cava Filter in subjects requiring IVC interruption to protect against pulmonary embolism (PE).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: Denali inferior vena cava filter Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter
Study Start Date : June 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Denali inferior vena cava filter
All subjects enrolled will receive the Denali vena cava filter.
Device: 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.
Other Names:
  • DL900J
  • DL900F

Primary Outcome Measures :
  1. Technical Success of Placement [ Time Frame: 6 months ]
    Technical success of filter placement is defined as the deployment of the filter such that the physician judges the location to be suitable to provide sufficient mechanical protection against Pulmonary Embolism.

  2. Clinical Success of Placement [ Time Frame: 6 months ]
    Is the one-sided lower limit of the 95% confidence interval for the observed clinical success rate at least 80%? Clinical success of filter placement is defined as freedom from subsequent Pulmonary Embolism (PE), filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.

  3. Technical Success of Retrieval [ Time Frame: 24 months ]
    Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.

  4. Clinical Success of Retrieval [ Time Frame: 24 months ]
    Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention. Only the 121 successful retrievals are counted here.

Secondary Outcome Measures :
  1. Rate of Recurring Pulmonary Embolism [ Time Frame: 24 months ]
    Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.

  2. Rate of New or Worsening Deep Vein Thrombosis [ Time Frame: 6 months ]
    Rate of new or worsening Deep Vein Thrombosis (DVT) from placement to the six month follow-up. Worsening DVT is defined as an extension of existing DVT to a new venous segment on ultrasound in patients that had DVT at the baseline visit.

  3. Filter Fracture [ Time Frame: 6 months ]
    Rate of filter fracture

  4. Filter Migration [ Time Frame: 6 months ]
    Rate of filter indwell complications of: migration >2cm.

  5. Filter Tilt at Placement [ Time Frame: Post-placement imaging ]
    Rate of filter indwell complications of: tilt >15°

  6. Filter Tilt at Retrieval [ Time Frame: Pre-retrieval imaging ]
    Rate of filter indwell complications of: tilt >15°

  7. Filter Penetration >3mm at Placement [ Time Frame: Post-placement ]
  8. Filter Penetration >3mm at Retrieval [ Time Frame: Pre-retrieval ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The subject or their legally authorized representative demonstrates understanding of the nature of the study and voluntarily provides written informed consent prior to any data collection or study procedures.
  • The subject is ≥ 21 years old, must be either a male or non-pregnant female with an expected lifespan sufficient to allow for completion of all study procedures. A negative pregnancy test result (urine or blood) is required prior to implant. If an enrolled female becomes pregnant prior to study completion, participation in the study will be terminated.
  • Based on Investigator judgment, the subject is at increased risk of PE requiring vena caval interruption. Note: Subjects diagnosed with acute DVT and/or PE must have objective confirmation based on imaging evidence of at least one of those diagnoses.
  • Patients without PE or venous thromboembolic disease (VTED) who are at risk of PE may be enrolled in this trial. However, enrollment of these patients will be limited to a maximum of 40% of the total sample size.
  • Based on Investigator's judgment, the subject has patent venous anatomy suitable for femoral or jugular/subclavian access for filter placement (e.g. no excessive tortuosity).
  • The IVC is ≤ 28 mm in diameter at the intended implantation site based on radiographic imaging evidence.
  • Based on Investigator's judgment, the filter can be safely placed such that the position of the filter tip is 1 cm below the lowest renal vein.
  • Retrieval of the filter is expected within 180 days post placement. At the six month follow up, if the Investigator determines that the filter continues to be clinically indicated, the filter may be left in place until the risk of PE has passed or left in permanently. All patients not having their filter retrieved at six months will continue be followed to 24 months or one month post filter retrieval, whichever comes first.
  • The subject has patent venous anatomy suitable for jugular access for retrieval of the filter based on imaging evidence within 48 hours prior to the filter placement procedure. Imaging mode will be at physician's discretion.
  • The subject is willing to comply with the protocol requirements and specified follow-up evaluations.

Exclusion Criteria:

  • The subject has a previously implanted filter in the IVC or superior vena cava (SVC).
  • The subject has a duplicated or left-sided IVC.
  • The subject has a severe spinal deformity that would impede access to the IVC for the filter placement or filter retrieval procedures.
  • The subject has a serum creatinine ≥ 2 mg/dl (and not on dialysis) within seven days of study enrollment. Patients on dialysis are allowed to participate in this trial.
  • The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
  • The subject has a life expectancy of < 25 months.
  • The subject has a known allergy or sensitivity to nickel or titanium.
  • The subject has a known allergy or sensitivity to iodinated contrast media, which cannot be adequately pre-medicated. NOTE: Alternative contrast agents are not permitted for the purposes of this study.
  • The subject is currently participating in an investigational drug or another device study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01305564

United States, Alabama
University of Alabama Birmingham Medical Center
Birmingham, Alabama, United States, 35249
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Florida Hospital
Orlando, Florida, United States, 32803
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Doctor's Hospital
Augusta, Georgia, United States, 30909
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
HeartCare Midwest
Peoria, Illinois, United States, 61637
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Minnesota
North Memorial Hospital
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Toledo Hospital
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
C. R. Bard
Principal Investigator: William Stavropoulos, MD The Hospital of the University of Pennsylvania

Responsible Party: C. R. Bard Identifier: NCT01305564     History of Changes
Other Study ID Numbers: BPV-09-007
First Posted: February 28, 2011    Key Record Dates
Results First Posted: December 7, 2015
Last Update Posted: March 30, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by C. R. Bard:
Pulmonary embolism (PE)
Deep vein thrombosis (DVT)
Vena cava
Vena cava filter
Inferior vena cava
Venous thromboembolic disease (VTED)

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases