A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System
This study is currently recruiting participants.
Verified March 2013 by C. R. Bard
Information provided by (Responsible Party):
C. R. Bard
First received: January 31, 2011
Last updated: March 14, 2013
Last verified: March 2013
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).
Device: Denali inferior vena cava filter
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter
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:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||21 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305564
|Contact: Ryan Melloy
C. R. Bard
||William Stavropoulos, MD
||The Hospital of the University of Pennsylvania
No publications provided
||C. R. Bard
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 31, 2011
||March 14, 2013
||United States: Food and Drug Administration
Keywords provided by C. R. Bard:
Deep vein thrombosis
Vena cava filter
Inferior vena cava
Venous thromboembolic disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Embolism and Thrombosis
Respiratory Tract Diseases