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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305564
• Other study ID #: BPV-09-007
• Status: Completed
• Phase: N/A
• First received: January 31, 2011
• Last updated: November 3, 2015
• Start date: June 2011
• Est. completion date: July 2015

Study information

• Verified date: November 2015
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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.

Locations

Country	Name	City	State
United States	Doctor's Hospital	Augusta	Georgia
United States	University of Alabama Birmingham Medical Center	Birmingham	Alabama
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	The Cleveland Clinic	Cleveland	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	Baptist Hospital of Miami	Miami	Florida
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Florida Hospital	Orlando	Florida
United States	HeartCare Midwest	Peoria	Illinois
United States	The Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Virginia Commonwealth University	Richmond	Virginia
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	Washington University in St. Louis	St. Louis	Missouri
United States	Tampa General Hospital	Tampa	Florida
United States	Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 PE.	6 months	No
Primary	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 PE, filter embolization, caval occlusion, filter and procedure related death, insertion adverse events (AEs), and technical failure of placement.	6 months	No
Primary	Technical Success of Retrieval	Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.	6 months	No
Primary	Clinical Success of Retrieval	Clinical success for retrieval is defined as successful technical retrieval of the filter without retrieval complications requiring intervention.	6 months	No
Secondary	Rate of Recurring PE	Rate of recurrent PE while the filter is indwelling or one month post-retrieval.	24 months	No
Secondary	Rate of Filter Complications	Rate of filter indwell complications of: fracture and migration >2cm.	6 months	No
Secondary	Rate of New or Worsening Deep Vein Thrombosis	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.	6 months	No
Secondary	Rate of Filter Complications	Rate of filter indwell complications of: tilt >15°	Retrieval	No
Secondary	Penetration >3mm From Placement to Retrieval		At placement	No
Secondary	Filter Penetration >3mm From Placement to Retrieval		Retrieval procedure	No

External Links

•   SIR practice guidelines for vena cava filters