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

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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Denali inferior vena cava filter

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical Success of Placement	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.	6 months
Clinical Success of Placement	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.	6 months
Technical Success of Retrieval	Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.	24 months
Clinical Success of Retrieval	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Recurring Pulmonary Embolism	Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.	24 months
Rate of New or Worsening Deep Vein Thrombosis	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.	6 months
Filter Fracture	Rate of filter fracture	6 months
Filter Migration	Rate of filter indwell complications of: migration >2cm.	6 months
Filter Tilt at Placement	Rate of filter indwell complications of: tilt >15°	Post-placement imaging
Filter Tilt at Retrieval	Rate of filter indwell complications of: tilt >15°	Pre-retrieval imaging
Filter Penetration >3mm at Placement		Post-placement
Filter Penetration >3mm at Retrieval		Pre-retrieval

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: William Stavropoulos, MD, The Hospital of the University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: February 29, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Deep vein thrombosis (DVT); Pulmonary embolism (PE); Inferior vena cava; Vena cava; Vena cava filter; Venous thromboembolic disease (VTED)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: BPV-09-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided