Trial Outcomes & Findings for VenaTech Convertible Vena Cava Filter U.S. Multi-Center Clinical Trial (NCT NCT01112917)
NCT ID: NCT01112917
Last Updated: 2016-07-11
Results Overview
Technical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a 'technically' successful conversion when the operator was unable to snare the filter hook during an attempted conversion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
6-months
Results posted on
2016-07-11
Participant Flow
All participants were first implanted with the VenaTech Convertible Filter. After the implantation, the study investigators assessed whether participants were eligible for conversion of the filter or required permanent filtration. If a subject was not eligible for conversion at 6-months, they were considered a permanent filtration subject.
Participant milestones
| Measure |
VenaTech Convertible Filter - Converted Filter
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
VenaTech Convertible Filter - Permanent Filtration
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
53
|
|
Overall Study
COMPLETED
|
89
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
| Measure |
VenaTech Convertible Filter - Converted Filter
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
VenaTech Convertible Filter - Permanent Filtration
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
|
|---|---|---|
|
Overall Study
Death
|
2
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Unable to Convert Filter
|
3
|
0
|
Baseline Characteristics
VenaTech Convertible Vena Cava Filter U.S. Multi-Center Clinical Trial
Baseline characteristics by cohort
| Measure |
VenaTech Convertible Filter
n=149 Participants
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 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
|
149 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-monthsTechnical success is defined as filter conversion without the loss of filter head components in the vasculature or incomplete opening of filtering legs. Further, in the analysis of the data, the sponsor did not count any filters as a 'technically' successful conversion when the operator was unable to snare the filter hook during an attempted conversion.
Outcome measures
| Measure |
VenaTech Convertible Filter - Converted Filters
n=96 Participants
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
|---|---|
|
Technical Success
|
89 participants
|
SECONDARY outcome
Timeframe: 6-monthsPopulation: There was one subject (007-006) excluded as no 6-month images were available although a 6-month assessment was conducted.
Outcome measures
| Measure |
VenaTech Convertible Filter - Converted Filters
n=88 Participants
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
|---|---|
|
Major Device-Related Adverse Events in Converted Subjects
|
0 participants
|
Adverse Events
VenaTech Convertible Filter
Serious events: 63 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VenaTech Convertible Filter
n=149 participants at risk
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
|---|---|
|
Blood and lymphatic system disorders
Compromise of Cardiac Valve Function due to Filter Embolization
|
0.67%
1/149 • Number of events 1 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
General disorders
Death
|
8.7%
13/149 • Number of events 13 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis (DVT)
|
2.7%
4/149 • Number of events 8 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Infections and infestations
Infection, including access site infection
|
2.0%
3/149 • Number of events 3 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
0.67%
1/149 • Number of events 1 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
General disorders
Other
|
38.3%
57/149 • Number of events 89 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Blood and lymphatic system disorders
Caval Thrombosis or Caval Occlusion
|
2.7%
4/149 • Number of events 4 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
Other adverse events
| Measure |
VenaTech Convertible Filter
n=149 participants at risk
VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration.
|
|---|---|
|
Blood and lymphatic system disorders
Access site thrombosis
|
0.67%
1/149 • Number of events 1 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Blood and lymphatic system disorders
Caval Thrombosis or Caval Occlusion
|
0.67%
1/149 • Number of events 1 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Blood and lymphatic system disorders
Deep Vein Thrombosis (DVT)
|
7.4%
11/149 • Number of events 15 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
Infections and infestations
Infection, including access site infection
|
0.67%
1/149 • Number of events 1 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
|
General disorders
Other
|
47.0%
70/149 • Number of events 166 • 6-Month Follow-up Period (through 6-months post-implant or post-filter conversion)
The "Other" adverse events were not broken down into separate specific Adverse Events, so are presented all under the "Other" category.
|
Additional Information
Andrea Fenton Abbs - Study Director
BRIGHT Research Partners
Phone: 612-298-7460
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60