Pulmonary EmbolismNCT01305564
A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System
A study testing Denali inferior vena cava filter in people with Pulmonary Embolism, run by C. R. Bard at 22 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Denali inferior vena cava filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesUnited States
- Study dates
- Jun 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Doctor's Hospital
Augusta, Georgia, 30909
University of Alabama Birmingham Medical Center
Birmingham, Alabama, 35249
Carolinas Medical Center
Charlotte, North Carolina, 28203
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
The Cleveland Clinic
Cleveland, Ohio, 44195
Riverside Methodist Hospital
Columbus, Ohio, 43214
Hartford Hospital
Hartford, Connecticut, 06102
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Kansas University Medical Center
Kansas City, Kansas, 66160
Lakeland Regional Medical Center
Lakeland, Florida, 33805
Baptist Hospital of Miami
Miami, Florida, 33176
Yale University School of Medicine
New Haven, Connecticut, 06510
Florida Hospital
Orlando, Florida, 32803
HeartCare Midwest
Peoria, Illinois, 61637
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Virginia Commonwealth University
Richmond, Virginia, 23219
North Memorial Hospital
Robbinsdale, Minnesota, 55422
Washington University in St. Louis
St Louis, Missouri, 63110
Tampa General Hospital
Tampa, Florida, 33606
Toledo Hospital
Toledo, Ohio, 43614
About this study
Official title: 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).
- Conditions
- Pulmonary Embolism
- Being tested
- Denali inferior vena cava filter
- Keywords
- Pulmonary embolism (PE), Deep vein thrombosis (DVT), Vena cava, Vena cava filter, Inferior vena cava, Venous thromboembolic disease (VTED)
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denali inferior vena cava filterDevice
Also called DL900J, DL900F
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.
| Study group | Role | What they receive |
|---|---|---|
| Denali inferior vena cava filter | Experimental | All subjects enrolled will receive the Denali vena cava filter. Receives: Device: Denali inferior vena cava filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (8)
Rate of Recurring Pulmonary Embolism
Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.
Measured: 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.
Measured: 6 months
Filter Fracture
Rate of filter fracture
Measured: 6 months
Filter Migration
Rate of filter indwell complications of: migration >2cm.
Measured: 6 months
Filter Tilt at Placement
Rate of filter indwell complications of: tilt >15°
Measured: Post-placement imaging
Filter Tilt at Retrieval
Rate of filter indwell complications of: tilt >15°
Measured: Pre-retrieval imaging
Filter Penetration >3mm at Placement
Measured: Post-placement
Filter Penetration >3mm at Retrieval
Measured: Pre-retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Stavropoulos, MD, Principal investigator, The Hospital of the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305564
- Sponsor's protocol ID
- BPV-09-007
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2011
- Last updated
- 30 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter
- ClinicalTrials.gov ID
- NCT01305564
- Acronym / sponsor ID
- BPV-09-007
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism (PE), Deep vein thrombosis (DVT), Vena cava, Vena cava filter, Inferior vena cava, Venous thromboembolic disease (VTED)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 7 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denali inferior vena cava filter | Experimental | Device: Denali inferior vena cava filterAll subjects enrolled will receive the Denali vena cava filter. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Denali inferior vena cava filterAlso: DL900J, DL900FThe 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. | Device | Denali inferior vena cava filter |
Primary outcome
Technical Success of Placement
Time frame: 6 months
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.
Clinical Success of Placement
Time frame: 6 months
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.
Technical Success of Retrieval
Time frame: 24 months
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: 24 months
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.
8 secondary outcomes
Rate of Recurring Pulmonary Embolism
Time frame: 24 months
Rate of New or Worsening Deep Vein Thrombosis
Time frame: 6 months
Filter Fracture
Time frame: 6 months
Filter Migration
Time frame: 6 months
Filter Tilt at Placement
Time frame: Post-placement imaging
Filter Tilt at Retrieval
Time frame: Pre-retrieval imaging
Filter Penetration >3mm at Placement
Time frame: Post-placement
Filter Penetration >3mm at Retrieval
Time frame: Pre-retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Stavropoulos, MD principal investigator
The Hospital of the University of Pennsylvania
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Denali inferior vena cava filter in people with Pulmonary Embolism, run by C. R. Bard at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success of Placement (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.