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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01305564
First received: January 31, 2011
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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 Intervention
Pulmonary Embolism
Device: Denali inferior vena cava filter

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Technical success of placement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 PE.

  • Clinical success of placement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 PE, filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.

  • Technical success of retrieval [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.

  • Clinical success of retrieval [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention.


Secondary Outcome Measures:
  • Rate of recurring PE [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Rate of recurrent PE while the filter is indwelling or one month post-retrieval.

  • Rate of filter complications [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of filter indwell complications of: fracture and migration >2cm.

  • Rate of new or worsening Deep Vein Thrombosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of new or worsening 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.

  • Rate of filter complications [ Time Frame: Retrieval ] [ Designated as safety issue: No ]
    Rate of filter indwell complications of: tilt >15° and penetration >3mm.


Estimated Enrollment: 200
Study Start Date: June 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. BPV will notify participating clinical sites as enrollment approaches this threshold.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305564

Locations
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
Investigators
Principal Investigator: William Stavropoulos, MD The Hospital of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

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
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014