Trial Outcomes & Findings for A Randomized, Concurrent Controlled Trial to Assess the Safety and Effectiveness of the Separator 3D as a Component of the Penumbra System in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke (NCT NCT01584609)
NCT ID: NCT01584609
Last Updated: 2018-09-13
Results Overview
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
At immediate post-procedure
Results posted on
2018-09-13
Participant Flow
Participant milestones
| Measure |
Penumbra System With Separator 3D
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
100
|
|
Overall Study
COMPLETED
|
86
|
96
|
|
Overall Study
NOT COMPLETED
|
12
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Penumbra System With Separator 3D
n=98 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 13.6 • n=98 Participants
|
66.5 years
STANDARD_DEVIATION 12.5 • n=100 Participants
|
66.9 years
STANDARD_DEVIATION 13 • n=198 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=98 Participants
|
54 Participants
n=100 Participants
|
111 Participants
n=198 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=98 Participants
|
46 Participants
n=100 Participants
|
87 Participants
n=198 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
98 Participants
n=98 Participants
|
100 Participants
n=100 Participants
|
198 Participants
n=198 Participants
|
PRIMARY outcome
Timeframe: At immediate post-procedurePopulation: Analysis population demonstrate outcomes of number of subjects that met endpoint.
Number of Participants with Angiographic revascularization of the occluded target vessel defined by mTICI grade 2-3
Outcome measures
| Measure |
Penumbra System With Separator 3D
n=94 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=96 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Number of Participants With Angiographic Revascularization of the Occluded Target Vessel
|
82 Participants
|
79 Participants
|
PRIMARY outcome
Timeframe: Within 24 hours post-procedureOutcome measures
| Measure |
Penumbra System With Separator 3D
n=98 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Number of Device-related Serious Adverse Events
|
4 Device-Related Serious Adverse Events
|
5 Device-Related Serious Adverse Events
|
PRIMARY outcome
Timeframe: Within 24 hours post-procedureOutcome measures
| Measure |
Penumbra System With Separator 3D
n=98 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Number of Procedure-related Serious Adverse Event
|
10 Procedure-related Serious Adverse Events
|
14 Procedure-related Serious Adverse Events
|
SECONDARY outcome
Timeframe: 30 days post-procedurePopulation: Analysis population demonstrate outcomes of number of subjects that met endpoint.
Defined by a 10 points or more improvement in the NIHSS at Discharge, a NIHSS score of 0-1 at Discharge; or a 30-day mRS score of 0-2. The NIHSS is a stroke scale that measures impairment caused by stroke. The Modified Rankin scale (mRS) measures neurological disability or dependence for stroke patients.
Outcome measures
| Measure |
Penumbra System With Separator 3D
n=97 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Good Clinical Outcome at 30 Days
|
58 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: at 90 days post-procedureOutcome measures
| Measure |
Penumbra System With Separator 3D
n=86 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=96 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Number of Participants With 90 Day mRS Score 0-2
|
39 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: At 90 days post-procedureOutcome measures
| Measure |
Penumbra System With Separator 3D
n=98 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
All Cause Mortality
|
19 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Within 24 hours post-procedureOutcome measures
| Measure |
Penumbra System With Separator 3D
n=98 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=100 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Number of Symptomatic Intracranial Hemorrhage
|
3 Symptomatic Intracranial Hemorrhage
|
5 Symptomatic Intracranial Hemorrhage
|
SECONDARY outcome
Timeframe: At 90 days post-procedureDefined by an mRS score of 0-2, or equal to the pre-stroke mRS score if the pre-stroke mRS score was higher than 2, or an improvement of 10 or more points on the NIHSS score
Outcome measures
| Measure |
Penumbra System With Separator 3D
n=86 Participants
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=96 Participants
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Good Neurological Outcome at 90 Days
|
56 Participants
|
55 Participants
|
Adverse Events
Penumbra System With Separator 3D
Serious events: 38 serious events
Other events: 81 other events
Deaths: 19 deaths
Penumbra System Alone
Serious events: 49 serious events
Other events: 83 other events
Deaths: 26 deaths
Serious adverse events
| Measure |
Penumbra System With Separator 3D
n=88 participants at risk
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=93 participants at risk
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Nervous system disorders
Nervous system disorders
|
21.6%
19/88 • Number of events 19 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
30.1%
28/93 • Number of events 28 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
10.2%
9/88 • Number of events 9 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
11.8%
11/93 • Number of events 11 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
9.1%
8/88 • Number of events 8 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
10.8%
10/93 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Cardiac disorders
Cardiac disorders
|
11.4%
10/88 • Number of events 10 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
7.5%
7/93 • Number of events 7 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Vascular disorders
Vascular disorders
|
1.1%
1/88 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
9.7%
9/93 • Number of events 9 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Infections and infestations
Infections and infestations
|
2.3%
2/88 • Number of events 2 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
6.5%
6/93 • Number of events 6 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
4.5%
4/88 • Number of events 4 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
1.1%
1/93 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
2.3%
2/88 • Number of events 2 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
2.2%
2/93 • Number of events 2 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
2.3%
2/88 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
2.2%
2/93 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
2.3%
2/88 • Number of events 2 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
1.1%
1/93 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Endocrine disorders
Endocrine disorders
|
0.00%
0/88 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
1.1%
1/93 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
General disorders
General disorders and administration site conditions
|
1.1%
1/88 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
0.00%
0/93 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/88 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
1.1%
1/93 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Investigations
Investigations
|
0.00%
0/88 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
1.1%
1/93 • Number of events 1 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
Other adverse events
| Measure |
Penumbra System With Separator 3D
n=88 participants at risk
Penumbra System with Separator 3D: The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
|
Penumbra System Alone
n=93 participants at risk
Penumbra System alone: The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
|
|---|---|---|
|
Nervous system disorders
Nervous System Disorders
|
54.5%
48/88 • Number of events 48 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
63.4%
59/93 • Number of events 59 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
30.7%
27/88 • Number of events 27 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
32.3%
30/93 • Number of events 30 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Infections and infestations
Infections and Infestations
|
31.8%
28/88 • Number of events 28 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
26.9%
25/93 • Number of events 25 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Vascular disorders
Vascular Disorder
|
30.7%
27/88 • Number of events 27 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
26.9%
25/93 • Number of events 25 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Cardiac disorders
Cardiac Disorders
|
31.8%
28/88 • Number of events 28 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
24.7%
23/93 • Number of events 23 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
23.9%
21/88 • Number of events 21 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
31.2%
29/93 • Number of events 29 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders
|
26.1%
23/88 • Number of events 23 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
25.8%
24/93 • Number of events 24 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
General disorders
General disorders and administration site conditions
|
28.4%
25/88 • Number of events 25 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
21.5%
20/93 • Number of events 20 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
27.3%
24/88 • Number of events 24 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
20.4%
19/93 • Number of events 19 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Psychiatric disorders
Psychiatric disorders
|
15.9%
14/88 • Number of events 14 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
20.4%
19/93 • Number of events 19 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
15.9%
14/88 • Number of events 14 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
12.9%
12/93 • Number of events 12 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
11.4%
10/88 • Number of events 10 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
9.7%
9/93 • Number of events 9 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Investigations
Investigations
|
14.8%
13/88 • Number of events 13 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
6.5%
6/93 • Number of events 6 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
10.2%
9/88 • Number of events 9 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
7.5%
7/93 • Number of events 7 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
9.1%
8/88 • Number of events 8 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
|
5.4%
5/93 • Number of events 5 • Procedure up to 90 days
Serious Adverse Events and Other (Not Including Serious): the total number of subjects analyzed is per protocol population. Data includes roll-in subjects and adjudicated by CEC. Events labeled as is in our Instructions for Use.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place