Trial Outcomes & Findings for A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System (NCT NCT01305564)
NCT ID: NCT01305564
Last Updated: 2016-03-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
6 months
Results posted on
2016-03-30
Participant Flow
Participant milestones
| Measure |
Denali Inferior Vena Cava Filter
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.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Denali Inferior Vena Cava Filter
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.
|
|---|---|
|
Overall Study
Death
|
21
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
A Prospective, Multi-Center Study of the Bard® Denali™ Retrievable Inferior Vena Cava Filter System
Baseline characteristics by cohort
| Measure |
Baseline Characteristics
n=200 Participants
All treated with Denali filter.
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 15.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsTechnical 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.
Outcome measures
| Measure |
Technical Success of Placement
n=200 Participants
Primary implant endpoint
|
|---|---|
|
Technical Success of Placement
|
99.5 percentage of participants
Interval 97.3 to 100.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Technical Success of Placement
n=189 Participants
Primary implant endpoint
|
|---|---|
|
Clinical Success of Placement
|
95.2 percentage of participants
Interval 91.2 to 97.8
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: 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.
Technical success for retrieval is defined as retrieval of the filter such that the entire filter is retrieved intact.
Outcome measures
| Measure |
Technical Success of Placement
n=124 Participants
Primary implant endpoint
|
|---|---|
|
Technical Success of Retrieval
|
97.6 percentage of participants
Interval 93.1 to 99.5
|
PRIMARY outcome
Timeframe: 24 monthsClinical 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.
Outcome measures
| Measure |
Technical Success of Placement
n=121 Participants
Primary implant endpoint
|
|---|---|
|
Clinical Success of Retrieval
|
99.2 percentage of participants
Interval 95.5 to 100.0
|
SECONDARY outcome
Timeframe: 24 monthsRate of recurrent Pulmonary Embolism while the filter is indwelling or one month post-retrieval.
Outcome measures
| Measure |
Technical Success of Placement
n=200 Participants
Primary implant endpoint
|
|---|---|
|
Rate of Recurring Pulmonary Embolism
|
3.0 percentage of participants
Interval 1.1 to 6.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The denominator of 188 is equal to the number of subjects completing the 6 month visit or with a filter retrieval procedure.
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.
Outcome measures
| Measure |
Technical Success of Placement
n=188 Participants
Primary implant endpoint
|
|---|---|
|
Rate of New or Worsening Deep Vein Thrombosis
|
10.1 percentage of participants
Interval 6.2 to 15.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Rate of filter fracture
Outcome measures
| Measure |
Technical Success of Placement
n=186 Participants
Primary implant endpoint
|
|---|---|
|
Filter Fracture
|
0 percentage of participants
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
Rate of filter indwell complications of: migration \>2cm.
Outcome measures
| Measure |
Technical Success of Placement
n=186 Participants
Primary implant endpoint
|
|---|---|
|
Filter Migration
|
0 percentage of participants
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: Post-placement imagingPopulation: Tilt was measured post-placement with vena cavagram.
Rate of filter indwell complications of: tilt \>15°
Outcome measures
| Measure |
Technical Success of Placement
n=200 Participants
Primary implant endpoint
|
|---|---|
|
Filter Tilt at Placement
|
0 percentage of participants
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: Pre-retrieval imagingPopulation: All patients undergoing a retrieval procedure.
Rate of filter indwell complications of: tilt \>15°
Outcome measures
| Measure |
Technical Success of Placement
n=124 Participants
Primary implant endpoint
|
|---|---|
|
Filter Tilt at Retrieval
|
0 percentage of participants
Interval 0.0 to 2.9
|
SECONDARY outcome
Timeframe: Post-placementPopulation: Penetration at Placement was measured immediately post-placement but prior to retrieval.
Outcome measures
| Measure |
Technical Success of Placement
n=200 Participants
Primary implant endpoint
|
|---|---|
|
Filter Penetration >3mm at Placement
|
1.5 percentage of participants
Interval 0.3 to 4.3
|
SECONDARY outcome
Timeframe: Pre-retrievalPopulation: The denominator of 124 is equal to the number of subjects undergoing a retrieval procedure with imaging to confirm penetration.
Outcome measures
| Measure |
Technical Success of Placement
n=124 Participants
Primary implant endpoint
|
|---|---|
|
Filter Penetration >3mm at Retrieval
|
1.6 percentage of participants
Interval 0.2 to 5.7
|
Adverse Events
Serious Adverse Events
Serious events: 90 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Serious Adverse Events
n=200 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Tachycardia
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Angina unstable
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Myocardial infarction
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Ear and labyrinth disorders
Ear pain
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.0%
6/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Ascites
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Stomatitis haemorrhagic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Oedema peripheral
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Catheter site haemorrhage
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Chest pain
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Non-cardiac chest pain
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Pyrexia
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Immune system disorders
Acute graft versus host disease
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Immune system disorders
Amyloidosis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Immune system disorders
Antiphospholipid syndrome
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Pneumonia
|
4.5%
9/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Sepsis
|
2.5%
5/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Cellulitis
|
2.0%
4/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Urinary tract infection
|
2.5%
5/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Bronchitis
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Abdominal abscess
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Abscess
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Bacteraemia
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Breast cellulitis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Diverticulitis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Extradural abscess
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Gastroenteritis viral
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Genitourinary tract infection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Herpes virus infection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Liver abscess
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Lobar pneumonia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Perineal abscess
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Pneumonia viral
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Postoperative wound infection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Pyelonephritis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Open wound
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Renal injury
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Vena cava injury
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Investigations
Troponin increased
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Gout
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Extraskeletal ossification
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Tendinous contracture
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastroesophageal cancer
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma metastatic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer recurrent
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Syncope
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Cervical cord compression
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Encephalopathy
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Loss of consciousness
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Presyncope
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Spinal claudication
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Psychiatric disorders
Mental status changes
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Psychiatric disorders
Depression
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
4/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Renal and urinary disorders
Haematuria
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Renal and urinary disorders
Anuria
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Reproductive system and breast disorders
Pelvic haematoma
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
5/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
4/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.5%
3/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Skin and subcutaneous tissue disorders
Decubitis ulcer
|
0.50%
1/200 • Number of events 1 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Deep vein thrombosis
|
7.5%
15/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Hypotension
|
2.5%
5/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Arterial thrombosis
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Shock haemorrhagic
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Vena cava thrombosis
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Venous thrombosis
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Aortic aneurysm
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Haemorrhage
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Superior vena caval stenosis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Congenital, familial and genetic disorders
Factor V Leiden mutation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Constipation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Hernia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Chest discomfort
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Clostridial Infection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Localized infection
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Staphylococcal sepsis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Injury, poisoning and procedural complications
Viith nerve injury
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Hypovolemia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
1.0%
2/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metatstatic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal carcinoma
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Facial palsy
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Piriformis syndrome
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Reproductive system and breast disorders
Gynacomastia
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Skin and subcutaneous tissue disorders
Skin hemorrhage
|
0.50%
1/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
Other adverse events
| Measure |
Serious Adverse Events
n=200 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.0%
22/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Constipation
|
9.0%
18/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.5%
15/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
13/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
12/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
10/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.0%
14/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Infections and infestations
Urinary Tract Infection
|
9.0%
18/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Nervous system disorders
Headache
|
5.5%
11/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
14/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Cardiac disorders
Tachycardia
|
5.5%
11/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
11/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Gastrointestinal disorders
Diarrhea
|
6.0%
12/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Peripheral edema
|
7.0%
14/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
General disorders
Pyrexia
|
6.0%
12/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
|
Vascular disorders
Deep Vein Thrombosis
|
6.0%
12/200 • Adverse event data were collected during the placement procedure and continued through the end of follow-up (24 months or 30-days post-retrieval).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place