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

NCT01305564 | Completed Results DMC

• 1 other identifier: BPV-09-007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 22

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).

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism (PE); Deep vein thrombosis (DVT); Vena cava; Vena cava filter; Inferior vena cava; Venous thromboembolic disease (VTED)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Rate of Recurring Pulmonary Embolism

  24 months

• Rate of New or Worsening Deep Vein Thrombosis

  6 months

• Filter Fracture

  6 months

• Filter Migration

  6 months

• Filter Tilt at Placement

  Post-placement imaging

Study Arms (1)

Denali inferior vena cava filter

EXPERIMENTAL

All subjects enrolled will receive the Denali vena cava filter.

Device: Denali inferior vena cava filter

Interventions

Denali inferior vena cava filter DEVICE

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.

Also known as: DL900J, DL900F

Denali inferior vena cava filter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (22)

University of Alabama Birmingham Medical Center

Birmingham, Alabama, 35249, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, 33805, United States

Location

Baptist Hospital of Miami

Miami, Florida, 33176, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Doctor's Hospital

Augusta, Georgia, 30909, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

HeartCare Midwest

Peoria, Illinois, 61637, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Toledo Hospital

Toledo, Ohio, 43614, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Results Point of Contact

• Title: Ryan Melloy
• Organization: Bard Peripheral Vascular

ryan.melloy@crbard.com

480-350-6074

Study Officials

• William Stavropoulos, MD

  The Hospital of the University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2011
• First Posted: February 28, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 30, 2016
• Results First Posted: December 7, 2015

Record last verified: 2016-02

Locations

US (22)