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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01305564
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : December 7, 2015
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Embolism
Intervention Device: Denali inferior vena cava filter
Enrollment 200

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Denali Inferior Vena Cava Filter
Hide Arm/Group Description

All subjects enrolled will receive the Denali vena cava filter.

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.

Period Title: Overall Study
Started 200
Completed 163
Not Completed 37
Reason Not Completed
Death             21
Lost to Follow-up             12
Withdrawal by Subject             1
Physician Decision             3
Arm/Group Title Baseline Characteristics
Hide Arm/Group Description All treated with Denali filter.
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
All subjects receiving a Denali vena cava filter.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants
56.6  (15.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
74
  37.0%
Male
126
  63.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Hispanic or Latino
11
   5.5%
Not Hispanic or Latino
189
  94.5%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
American Indian or Alaska Native
1
   0.5%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
31
  15.5%
White
164
  82.0%
More than one race
0
   0.0%
Unknown or Not Reported
4
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants
200
1.Primary Outcome
Title Technical Success of Placement
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Technical Success of Placement
Hide Arm/Group Description:
Primary implant endpoint
Overall Number of Participants Analyzed 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.5
(97.3 to 100)
2.Primary Outcome
Title Clinical Success of Placement
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 189 is equal to all of the subjects that completed the 6 month visit, had their filter retrieved, or experienced a component of the clinical success of placement endpoint regardless of follow-up duration.
Arm/Group Title Clinical Success of Placement
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.2
(91.2 to 97.8)
3.Primary Outcome
Title Technical Success of Retrieval
Hide Description Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 124 is equal to the number of subjects that had a filter retrieval procedure (successful and unsuccessful retrievals). Subjects were not required to have a retrieval procedure.
Arm/Group Title Technical Success of Retrieval
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.6
(93.1 to 99.5)
4.Primary Outcome
Title Clinical Success of Retrieval
Hide Description 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.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clinical Success of Retrieval
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 121
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.2
(95.5 to 100)
5.Secondary Outcome
Title Rate of Recurring Pulmonary Embolism
Hide Description Rate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recurrent PE
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.0
(1.1 to 6.4)
6.Secondary Outcome
Title Rate of New or Worsening Deep Vein Thrombosis
Hide Description 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.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.
Arm/Group Title New or Worsening DVT
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 188
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
10.1
(6.2 to 15.3)
7.Secondary Outcome
Title Filter Fracture
Hide Description Rate of filter fracture
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of fracture.
Arm/Group Title Filter Fracture
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 186
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 2.0)
8.Secondary Outcome
Title Filter Migration
Hide Description Rate of filter indwell complications of: migration >2cm.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 186 is equal to the number of subjects that completed a 6 month follow-up or had their filter retrieved, with imaging completed to confirm lack of migration.
Arm/Group Title Filter Migration >2 cm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 186
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 2.0)
9.Secondary Outcome
Title Filter Tilt at Placement
Hide Description Rate of filter indwell complications of: tilt >15°
Time Frame Post-placement imaging
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Tilt was measured post-placement with vena cavagram.
Arm/Group Title Filter Tilt
Hide Arm/Group Description:
At Implant
Overall Number of Participants Analyzed 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 1.8)
10.Secondary Outcome
Title Filter Tilt at Retrieval
Hide Description Rate of filter indwell complications of: tilt >15°
Time Frame Pre-retrieval imaging
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients undergoing a retrieval procedure.
Arm/Group Title Filter Tilt
Hide Arm/Group Description:
At Retrieval
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0.0 to 2.9)
11.Secondary Outcome
Title Filter Penetration >3mm at Placement
Hide Description [Not Specified]
Time Frame Post-placement
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Penetration at Placement was measured immediately post-placement but prior to retrieval.
Arm/Group Title Filter Penetration at Placement
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 200
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.5
(0.3 to 4.3)
12.Secondary Outcome
Title Filter Penetration >3mm at Retrieval
Hide Description [Not Specified]
Time Frame Pre-retrieval
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.
Arm/Group Title Filter Penetration at Retrieval
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.6
(0.2 to 5.7)
Time Frame Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Serious Adverse Events
Hide Arm/Group Description

Serious Adverse Events are reported for all 200 subjects and all serious events are reported.

Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events.

All-Cause Mortality
Serious Adverse Events
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Serious Adverse Events
Affected / at Risk (%) # Events
Total   90/200 (45.00%)    
Blood and lymphatic system disorders   
Anaemia  1  3/200 (1.50%) 
Thrombocytopenia  1  3/200 (1.50%) 
Disseminated intravascular coagulation  1  1/200 (0.50%) 
Haemolysis  1  1/200 (0.50%) 
Lymphadenopathy  1  1/200 (0.50%)  1
Splenomegaly  1  1/200 (0.50%) 
Cardiac disorders   
Cardiac failure congestive  1  3/200 (1.50%) 
Tachycardia  1  2/200 (1.00%) 
Acute coronary syndrome  1  1/200 (0.50%) 
Angina unstable  1  1/200 (0.50%) 
Atrial fibrillation  1  1/200 (0.50%) 
Cardiac arrest  1  1/200 (0.50%) 
Cardio-respiratory arrest  1  2/200 (1.00%) 
Myocardial infarction  1  2/200 (1.00%) 
Coronary artery disease  1  2/200 (1.00%) 
Congenital, familial and genetic disorders   
Factor V Leiden mutation  1  1/200 (0.50%) 
Ear and labyrinth disorders   
Ear pain  1  1/200 (0.50%) 
Gastrointestinal disorders   
Abdominal pain  1  6/200 (3.00%) 
Gastrointestinal haemorrhage  1  2/200 (1.00%) 
Ascites  1  1/200 (0.50%) 
Duodenal ulcer haemorrhage  1  1/200 (0.50%) 
Localised intraabdominal fluid collection  1  1/200 (0.50%) 
Retroperitoneal haemorrhage  1  1/200 (0.50%) 
Small intestinal obstruction  1  1/200 (0.50%) 
Stomatitis haemorrhagic  1  1/200 (0.50%) 
Constipation  1  1/200 (0.50%) 
Pancreatitis  1  1/200 (0.50%) 
General disorders   
Oedema peripheral  1  2/200 (1.00%) 
Catheter site haemorrhage  1  1/200 (0.50%) 
Chest pain  1  1/200 (0.50%) 
Non-cardiac chest pain  1  1/200 (0.50%) 
Pyrexia  1  2/200 (1.00%) 
Hernia  1  1/200 (0.50%) 
Chest discomfort  1  1/200 (0.50%) 
Hepatobiliary disorders   
Cholecystitis  1  3/200 (1.50%) 
Cholecystitis chronic  1  1/200 (0.50%) 
Cholelithiasis  1  1/200 (0.50%) 
Immune system disorders   
Acute graft versus host disease  1  1/200 (0.50%) 
Amyloidosis  1  1/200 (0.50%) 
Antiphospholipid syndrome  1  1/200 (0.50%) 
Infections and infestations   
Pneumonia  1  9/200 (4.50%) 
Sepsis  1  5/200 (2.50%) 
Cellulitis  1  4/200 (2.00%) 
Urinary tract infection  1  5/200 (2.50%) 
Bronchitis  1  2/200 (1.00%) 
Abdominal abscess  1  1/200 (0.50%) 
Abscess  1  1/200 (0.50%) 
Bacteraemia  1  2/200 (1.00%) 
Breast cellulitis  1  1/200 (0.50%) 
Diverticulitis  1  1/200 (0.50%) 
Extradural abscess  1  1/200 (0.50%) 
Gastroenteritis viral  1  1/200 (0.50%) 
Genitourinary tract infection  1  1/200 (0.50%) 
Herpes virus infection  1  1/200 (0.50%) 
Liver abscess  1  1/200 (0.50%) 
Lobar pneumonia  1  1/200 (0.50%) 
Perineal abscess  1  1/200 (0.50%) 
Pneumonia staphylococcal  1  1/200 (0.50%) 
Pneumonia viral  1  1/200 (0.50%) 
Postoperative wound infection  1  1/200 (0.50%) 
Pyelonephritis  1  1/200 (0.50%) 
Clostridial Infection  1  1/200 (0.50%) 
Localized infection  1  1/200 (0.50%) 
Staphylococcal sepsis  1  1/200 (0.50%) 
Injury, poisoning and procedural complications   
Subdural haematoma  1  3/200 (1.50%) 
Fall  1  2/200 (1.00%) 
Postoperative ileus  1  2/200 (1.00%) 
Brain herniation  1  1/200 (0.50%) 
Drug toxicity  1  1/200 (0.50%) 
Incisional hernia  1  1/200 (0.50%) 
Joint injury  1  1/200 (0.50%) 
Open wound  1  1/200 (0.50%) 
Procedural site reaction  1  1/200 (0.50%) 
Renal injury  1  1/200 (0.50%) 
Spinal compression fracture  1  1/200 (0.50%) 
Vascular graft complication  1  1/200 (0.50%) 
Vena cava injury  1  1/200 (0.50%) 
Hip fracture  1  1/200 (0.50%) 
Humerus fracture  1  1/200 (0.50%) 
Joint dislocation  1  1/200 (0.50%) 
Viith nerve injury  1  1/200 (0.50%) 
Investigations   
Troponin increased  1  1/200 (0.50%) 
Metabolism and nutrition disorders   
Anorexia  1  1/200 (0.50%) 
Gout  1  1/200 (0.50%) 
Hyponatraemia  1  1/200 (0.50%) 
Dehydration  1  1/200 (0.50%) 
Failure to thrive  1  1/200 (0.50%) 
Hypovolemia  1  1/200 (0.50%) 
Type 2 diabetes mellitus  1  1/200 (0.50%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  2/200 (1.00%) 
Extraskeletal ossification  1  1/200 (0.50%) 
Groin pain  1  1/200 (0.50%) 
Haemarthrosis  1  1/200 (0.50%) 
Joint ankylosis  1  1/200 (0.50%) 
Muscular weakness  1  1/200 (0.50%) 
Musculoskeletal pain  1  2/200 (1.00%) 
Pain in extremity  1  1/200 (0.50%) 
Pathological fracture  1  1/200 (0.50%) 
Tendinous contracture  1  1/200 (0.50%) 
Fasciitis  1  1/200 (0.50%) 
Foot deformity  1  1/200 (0.50%) 
Musculoskeletal chest pain  1  1/200 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/200 (0.50%) 
Brain neoplasm  1  1/200 (0.50%) 
Gastroesophageal cancer  1  1/200 (0.50%) 
Hodgkin's disease  1  1/200 (0.50%) 
Intestinal adenocarcinoma  1  1/200 (0.50%) 
Liposarcoma metastatic  1  1/200 (0.50%) 
Metastases to meninges  1  1/200 (0.50%) 
Multiple myeloma  1  1/200 (0.50%) 
Pancreatic carcinoma metastatic  1  1/200 (0.50%) 
Urethral cancer recurrent  1  1/200 (0.50%) 
Colon cancer metastatic  1  2/200 (1.00%) 
Adenocarcinoma pancreas  1  1/200 (0.50%) 
Lung cancer metatstatic  1  1/200 (0.50%) 
Malignant neoplasm progression  1  1/200 (0.50%) 
Esophageal carcinoma  1  1/200 (0.50%) 
Rectal cancer  1  1/200 (0.50%) 
Skin cancer  1  1/200 (0.50%) 
Small intestine carcinoma metastatic  1  1/200 (0.50%) 
Nervous system disorders   
Cerebrovascular accident  1  3/200 (1.50%) 
Syncope  1  3/200 (1.50%) 
Carpal tunnel syndrome  1  1/200 (0.50%) 
Cervical cord compression  1  1/200 (0.50%) 
Encephalopathy  1  1/200 (0.50%) 
Loss of consciousness  1  1/200 (0.50%) 
Presyncope  1  1/200 (0.50%) 
Spinal claudication  1  1/200 (0.50%) 
Amyotrophic lateral sclerosis  1  1/200 (0.50%) 
Facial palsy  1  1/200 (0.50%) 
Piriformis syndrome  1  1/200 (0.50%) 
Psychiatric disorders   
Mental status changes  1  2/200 (1.00%) 
Depression  1  1/200 (0.50%) 
Renal and urinary disorders   
Renal failure acute  1  4/200 (2.00%) 
Haematuria  1  3/200 (1.50%) 
Anuria  1  1/200 (0.50%) 
Nephrolithiasis  1  1/200 (0.50%) 
Urinary retention  1  2/200 (1.00%) 
Reproductive system and breast disorders   
Pelvic haematoma  1  1/200 (0.50%) 
Peyronie's disease  1  1/200 (0.50%) 
Gynacomastia  1  1/200 (0.50%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  5/200 (2.50%) 
Dyspnoea  1  3/200 (1.50%) 
Respiratory failure  1  4/200 (2.00%) 
Acute respiratory failure  1  2/200 (1.00%) 
Chronic obstructive pulmonary disease  1  3/200 (1.50%) 
Hypoxia  1  2/200 (1.00%) 
Atelectasis  1  1/200 (0.50%) 
Dyspnoea exertional  1  1/200 (0.50%) 
Haemoptysis  1  1/200 (0.50%) 
Pleural effusion  1  1/200 (0.50%) 
Bronchial secretion retention  1  1/200 (0.50%) 
Skin and subcutaneous tissue disorders   
Decubitis ulcer  1  1/200 (0.50%)  1
Skin ulcer  1  1/200 (0.50%) 
Skin hemorrhage  1  1/200 (0.50%) 
Vascular disorders   
Deep vein thrombosis  1  15/200 (7.50%) 
Hypotension  1  5/200 (2.50%) 
Arterial thrombosis  1  2/200 (1.00%) 
Shock haemorrhagic  1  2/200 (1.00%) 
Vena cava thrombosis  1  2/200 (1.00%) 
Venous thrombosis  1  2/200 (1.00%) 
Aortic aneurysm  1  1/200 (0.50%) 
Haemorrhage  1  1/200 (0.50%) 
Superior vena caval stenosis  1  1/200 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Serious Adverse Events
Affected / at Risk (%) # Events
Total   138/200 (69.00%)    
Blood and lymphatic system disorders   
Anaemia  1  14/200 (7.00%) 
Cardiac disorders   
Tachycardia  1  11/200 (5.50%) 
Gastrointestinal disorders   
Nausea  1  22/200 (11.00%) 
Constipation  1  18/200 (9.00%) 
Abdominal Pain  1  15/200 (7.50%) 
Vomiting  1  13/200 (6.50%) 
Diarrhea  1  12/200 (6.00%) 
General disorders   
Peripheral edema  1  14/200 (7.00%) 
Pyrexia  1  12/200 (6.00%) 
Infections and infestations   
Urinary Tract Infection  1  18/200 (9.00%) 
Musculoskeletal and connective tissue disorders   
Back Pain  1  12/200 (6.00%) 
Arthralgia  1  10/200 (5.00%) 
Pain in Extremity  1  14/200 (7.00%) 
Nervous system disorders   
Headache  1  11/200 (5.50%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  11/200 (5.50%) 
Vascular disorders   
Deep Vein Thrombosis  1  12/200 (6.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ryan Melloy
Organization: Bard Peripheral Vascular
Phone: 480-350-6074
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01305564     History of Changes
Other Study ID Numbers: BPV-09-007
First Submitted: January 31, 2011
First Posted: February 28, 2011
Results First Submitted: November 3, 2015
Results First Posted: December 7, 2015
Last Update Posted: March 30, 2016