Trial Outcomes & Findings for The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study (NCT NCT05409976)
NCT ID: NCT05409976
Last Updated: 2026-04-29
Results Overview
Composite primary endpoint consisting of freedom from the following: * Loss of primary patency through 12-month follow-up * Stent embolization through 12-month follow-up * Device- or procedure-related death through 30 days * Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days * Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention * Device- or procedure-related major bleeding events through 30 days
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
136 participants
Primary outcome timeframe
12 months
Results posted on
2026-04-29
Participant Flow
The Initial Subject Analysis Population reflects the initial 89 subjects treated, as well as 15 screen failures, for a total of 104 subjects. The Supplemental Global Analysis Population subjects represent an additional 32 subjects consented (including 23 treated subjects) as part of a Global Analysis Population of 136 subjects (112 treated).
Participant milestones
| Measure |
Initial Subject Analysis Population
Subjects who were consented to the VNS 21-05 study, regardless of if they received a GORE VIAFORT Vascular Stent. This arm includes the first 104 participants consented.
|
Supplemental Global Analysis Population Subjects
Subjects who were consented to the VNS 21-05 study, regardless of if they received a GORE VIAFORT Vascular Stent. This arm represents the additional 32 participants consented to round out the Global Analysis Population.
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
32
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
104
|
32
|
Reasons for withdrawal
| Measure |
Initial Subject Analysis Population
Subjects who were consented to the VNS 21-05 study, regardless of if they received a GORE VIAFORT Vascular Stent. This arm includes the first 104 participants consented.
|
Supplemental Global Analysis Population Subjects
Subjects who were consented to the VNS 21-05 study, regardless of if they received a GORE VIAFORT Vascular Stent. This arm represents the additional 32 participants consented to round out the Global Analysis Population.
|
|---|---|---|
|
Overall Study
Still in Study
|
85
|
23
|
|
Overall Study
Death
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Screen Failure
|
15
|
9
|
Baseline Characteristics
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
Baseline characteristics by cohort
| Measure |
Initial Subject Analysis Population
n=89 Participants
Hypothesis-driven test group (n=89 treated subjects)
|
Supplemental Global Analysis Population Subjects
n=23 Participants
Hypothesis-driven test group (n=23 treated subjects)
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.9 years
STANDARD_DEVIATION 16.81 • n=9 Participants
|
48.7 years
STANDARD_DEVIATION 12.79 • n=24 Participants
|
50.5 years
STANDARD_DEVIATION 16.04 • n=23 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
46 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=9 Participants
|
11 Participants
n=24 Participants
|
66 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
72 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
28 Participants
n=9 Participants
|
8 Participants
n=24 Participants
|
36 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=9 Participants
|
3 Participants
n=24 Participants
|
19 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
White
|
44 Participants
n=9 Participants
|
12 Participants
n=24 Participants
|
56 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
28 Participants
n=9 Participants
|
8 Participants
n=24 Participants
|
36 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=9 Participants
|
15 Participants
n=24 Participants
|
70 Participants
n=23 Participants
|
|
Region of Enrollment
United Kingdom
|
17 Participants
n=9 Participants
|
5 Participants
n=24 Participants
|
22 Participants
n=23 Participants
|
|
Region of Enrollment
Italy
|
4 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Region of Enrollment
Ireland
|
2 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=23 Participants
|
|
Region of Enrollment
Germany
|
5 Participants
n=9 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=23 Participants
|
|
Region of Enrollment
Australia
|
5 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=23 Participants
|
|
Region of Enrollment
New Zealand
|
1 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The Per Protocol population and the Intent to Treat population were identical in this study. Of the 89 treated subjects, 79 were evaluable for the primary composite endpoint.
Composite primary endpoint consisting of freedom from the following: * Loss of primary patency through 12-month follow-up * Stent embolization through 12-month follow-up * Device- or procedure-related death through 30 days * Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days * Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention * Device- or procedure-related major bleeding events through 30 days
Outcome measures
| Measure |
Initial Subject Analysis Population
n=79 Participants
All evaluable treated subjects in the Initial Subject Analysis Population. Combined results including all 112 treated subjects will be reported in a separate Outcome Measure after primary endpoint data collection is complete for all 112 treated subjects.
|
|---|---|
|
Initial Subject Analysis Population: Percentage of Subjects With Freedom From the Composite Endpoint of Effectiveness and Safety Events
|
74.7 percentage of participants
Interval 66.6 to 82.7
|
PRIMARY outcome
Timeframe: 12 monthsComposite primary endpoint consisting of freedom from the following: * Loss of primary patency through 12-month follow-up * Stent embolization through 12-month follow-up * Device- or procedure-related death through 30 days * Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days * Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention * Device- or procedure-related major bleeding events through 30 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsNumber of subjects with freedom from both: * stent occlusion due to restenosis or thrombosis as confirmed with imaging, and * clinically driven target lesion revascularization as confirmed with imaging and adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsNumber of subjects with freedom from permanent loss of blood flow through the device, regardless of reintervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsNumber of subjects with repeat endovascular procedures (e.g., PTA, stenting, thrombectomy/thrombolysis) to restore flow, performed within the margins of the investigational devices due to ≥50% restenosis of the target lesion as measured via imaging AND the failure to improve or recurrence of venous origin leg pain or venous edema related to the target lesion present at baseline, or the onset of new symptoms including venous origin pain and venous edema related to the target lesion.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsNumber of subjects with device fracture as confirmed with imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsNumber of subjects with stent embolization as confirmed with imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysNumber of subjects with device- or procedure-related death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysNumber of subjects with clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysNumber of subjects with device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 daysNumber of subjects with device- or procedure-related major bleeding events through 30 days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsChange in Revised Venous Clinical Severity Scale (rVCSS) Measurement through 60-month follow-up compared to baseline prior to treatment. Note: The rVCSS scale ranges from 0 to 30, with higher scores reflecting worse symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsChange in Revised Venous Clinical Severity Scale (rVCSS) Pain Measurement through 60-month follow-up compared to baseline prior to treatment. Note: The rVCSS Pain scale ranges from 0 to 3, with higher scores reflecting worse pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsChange in Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) Measurement through 60-month follow-up compared to baseline prior to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsChange in Villalta Measurement through 60-month follow-up compared to baseline prior to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 monthsChange in 5 Level EuroQol-5 Dimension (EQ-5D-5L) Measurement through 60-month follow-up compared to baseline prior to treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Index procedure (post-op day 0)Number of subjects with successful delivery and deployment of the stent to the intended location, and removal of delivery system.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Index procedure (post-op day 0)Number of subjects with evidence of ≤50% residual stenosis at the conclusion of the index procedure as measured by IVUS or venogram.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Index procedure through hospital discharge (discharge estimated as up to 30 days post-treatment)Number of subjects with lesion success and the absence of major adverse events (i.e., stent embolization, device- or procedure-related death, clinically significant pulmonary embolism, device- or procedure-related vascular injury requiring surgical or endovascular intervention, and device- or procedure-related major bleeding) prior to discharge.
Outcome measures
Outcome data not reported
Adverse Events
Initial Subject Analysis Population
Serious events: 45 serious events
Other events: 25 other events
Deaths: 2 deaths
Supplemental Global Analysis Population Subjects
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Subject Analysis Population
n=104 participants at risk
All subjects that consented to the study in the Initial Subject Analysis Population (n=104; 89 treated; 15 screen failures).
|
Supplemental Global Analysis Population Subjects
n=32 participants at risk
All subjects that consented to the study (both treated subjects and those considered screen failures) in the Supplemental Global Analysis Population Subjects (n=32; 23 treated; 9 screen failures).
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute massive pulmonary embolism
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.96%
1/104 • Number of events 3 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Skin and subcutaneous tissue disorders
Venous stasis ulcer
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Claudication
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Deep vein thrombosis leg
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Haematoma
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
2/104 • Number of events 2 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Blood and lymphatic system disorders
Blood loss anemia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Cardiac disorders
Cardiac arrest
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Cardiac disorders
Unstable angina
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Eye disorders
Ocular fistula
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Duodenal erosion
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Hemorrhagic shock
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer bleeding
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Hemoperitoneum
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Nausea
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Hypertension
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Vascular disorders
Hypotension
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Right lower quadrant pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Small bowel obstruction
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Gastrointestinal disorders
Upper gastrointestinal bleeding
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
General body pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
In-stent venous restenosis
|
6.7%
7/104 • Number of events 8 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
Non-cardiac chest pain
|
1.9%
2/104 • Number of events 2 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
Puncture site hematoma
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
Residual pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
Weakness
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Immune system disorders
Anaphylaxis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Bronchitis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Cellulitis of leg
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Coronavirus infection
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Hospital acquired pneumonia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Lower lobe pneumonia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Methicillin-sensitive Staphylococcus aureus bacteremia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/104 • Number of events 3 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Pneumonia bacterial
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Sepsis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Septic arthritis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
UTI
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Urinary tract infection
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Infections and infestations
Wound infection
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Lip laceration
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Liver rupture
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Postoperative pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Vascular access site bleeding
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Vascular access site hematoma
|
1.9%
2/104 • Number of events 2 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Investigations
Gastrointestinal stoma output increased
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Investigations
INR increased
|
0.00%
0/104 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/104 • Number of events 2 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Back pain aggravated
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Knee osteoarthritis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Nervous system disorders
Acute toxic metabolic encephalopathy
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Nervous system disorders
Light headedness
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Nervous system disorders
Seizure
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Nervous system disorders
Syncope
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Nervous system disorders
Weakness left or right side
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Product Issues
Stent occlusion
|
2.9%
3/104 • Number of events 3 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Product Issues
Thrombosis in device
|
8.7%
9/104 • Number of events 10 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
3.1%
1/32 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Psychiatric disorders
Anxiety
|
0.96%
1/104 • Number of events 2 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Psychiatric disorders
Delirium
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Psychiatric disorders
Panic attack
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Respiratory, thoracic and mediastinal disorders
Acute dyspnea
|
0.96%
1/104 • Number of events 1 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
Other adverse events
| Measure |
Initial Subject Analysis Population
n=104 participants at risk
All subjects that consented to the study in the Initial Subject Analysis Population (n=104; 89 treated; 15 screen failures).
|
Supplemental Global Analysis Population Subjects
n=32 participants at risk
All subjects that consented to the study (both treated subjects and those considered screen failures) in the Supplemental Global Analysis Population Subjects (n=32; 23 treated; 9 screen failures).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.7%
7/104 • Number of events 7 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
General disorders
In-stent venous restenosis
|
6.7%
7/104 • Number of events 7 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
6/104 • Number of events 6 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
11.5%
12/104 • Number of events 12 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
0.00%
0/32 • Adverse events for all subjects were reported from consent through follow up, with the longest follow up duration to date being 944 days post-treatment. Final adverse event collection will be at study completion (5 years post-treatment).
This data includes all adverse events for all enrolled subjects, including screen failures who did not receive the study device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place