Clinical trial NCT01305564: A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System
Official title: A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary embolism (PE)
Deep vein thrombosis (DVT)
Vena cava
Vena cava filter
Inferior vena cava
Venous thromboembolic disease (VTED)
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.
* 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.

Primary outcomes:
measure: Technical Success of Placement
timeFrame: 6 months
measure: Clinical Success of Placement
timeFrame: 6 months
measure: Technical Success of Retrieval
timeFrame: 24 months
measure: Clinical Success of Retrieval
timeFrame: 24 months
Secondary outcomes:
measure: Rate of Recurring Pulmonary Embolism
timeFrame: 24 months
measure: Rate of New or Worsening Deep Vein Thrombosis
timeFrame: 6 months
measure: Filter Fracture
timeFrame: 6 months
measure: Filter Migration
timeFrame: 6 months
measure: Filter Tilt at Placement
timeFrame: Post-placement imaging
measure: Filter Tilt at Retrieval
timeFrame: Pre-retrieval imaging
measure: Filter Penetration >3mm at Placement
timeFrame: Post-placement
measure: Filter Penetration >3mm at Retrieval
timeFrame: Pre-retrieval
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham Medical Center
state: Alabama
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Augusta
country: United States
facility: Doctor's Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Peoria
country: United States
facility: HeartCare Midwest
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: The Hospital of the University of Pennsylvania
name: William Stavropoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: