Trial Outcomes & Findings for ASSIST Registry Studying Various Operator Techniques (NCT NCT03845491)

NCT ID: NCT03845491

Last Updated: 2025-05-13

Results Overview

This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.

Recruitment status

COMPLETED

Target enrollment

1492 participants

Primary outcome timeframe

90 Days (±14 days)

Results posted on

2025-05-13

Participant Flow

Participant milestones

Participant milestones
Measure
SR Classic
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Overall Study
STARTED
247
697
548
Overall Study
COMPLETED
209
563
432
Overall Study
NOT COMPLETED
38
134
116

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SR Classic
n=247 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=697 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=548 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Total
n=1492 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=247 Participants
0 Participants
n=697 Participants
1 Participants
n=548 Participants
1 Participants
n=1492 Participants
Age, Categorical
Between 18 and 65 years
66 Participants
n=247 Participants
191 Participants
n=697 Participants
192 Participants
n=548 Participants
449 Participants
n=1492 Participants
Age, Categorical
>=65 years
181 Participants
n=247 Participants
506 Participants
n=697 Participants
355 Participants
n=548 Participants
1042 Participants
n=1492 Participants
Age, Continuous
71.4 Years
STANDARD_DEVIATION 14.3 • n=247 Participants
71.8 Years
STANDARD_DEVIATION 13.1 • n=697 Participants
68.1 Years
STANDARD_DEVIATION 15.4 • n=548 Participants
70.4 Years
STANDARD_DEVIATION 14.3 • n=1492 Participants
Sex: Female, Male
Female
121 Participants
n=247 Participants
379 Participants
n=697 Participants
281 Participants
n=548 Participants
781 Participants
n=1492 Participants
Sex: Female, Male
Male
126 Participants
n=247 Participants
318 Participants
n=697 Participants
267 Participants
n=548 Participants
711 Participants
n=1492 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
Canada
1 participants
n=247 Participants
12 participants
n=697 Participants
2 participants
n=548 Participants
15 participants
n=1492 Participants
Region of Enrollment
South Korea
20 participants
n=247 Participants
33 participants
n=697 Participants
11 participants
n=548 Participants
64 participants
n=1492 Participants
Region of Enrollment
Belgium
14 participants
n=247 Participants
45 participants
n=697 Participants
3 participants
n=548 Participants
62 participants
n=1492 Participants
Region of Enrollment
United States
47 participants
n=247 Participants
327 participants
n=697 Participants
280 participants
n=548 Participants
654 participants
n=1492 Participants
Region of Enrollment
Czechia
20 participants
n=247 Participants
16 participants
n=697 Participants
4 participants
n=548 Participants
40 participants
n=1492 Participants
Region of Enrollment
Italy
1 participants
n=247 Participants
42 participants
n=697 Participants
52 participants
n=548 Participants
95 participants
n=1492 Participants
Region of Enrollment
United Kingdom
0 participants
n=247 Participants
0 participants
n=697 Participants
1 participants
n=548 Participants
1 participants
n=1492 Participants
Region of Enrollment
France
0 participants
n=247 Participants
17 participants
n=697 Participants
2 participants
n=548 Participants
19 participants
n=1492 Participants
Region of Enrollment
Switzerland
0 participants
n=247 Participants
45 participants
n=697 Participants
8 participants
n=548 Participants
53 participants
n=1492 Participants
Region of Enrollment
Germany
0 participants
n=247 Participants
115 participants
n=697 Participants
52 participants
n=548 Participants
167 participants
n=1492 Participants
Region of Enrollment
Spain
144 participants
n=247 Participants
45 participants
n=697 Participants
133 participants
n=548 Participants
322 participants
n=1492 Participants

PRIMARY outcome

Timeframe: 90 Days (±14 days)

Population: Available mRS scores at 90Days (±14 days) of the enrolled population

This measure assesses clinical outcome using the Modified Rankin Scale (mRS). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all; no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability, and higher score indicates increased disability.

Outcome measures

Outcome measures
Measure
SR Classic
n=237 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=666 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=506 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Percentage of Subjects Achieved Good Functional Outcome (mRS 0-2) at Day 90
140 Participants
351 Participants
273 Participants

PRIMARY outcome

Timeframe: At the time of procedure, after the first pass

Population: Available core lab adjudicated procedural endpoint data of the enrolled subjects.

This outcome measures percentage of subjects who achieved complete reperfusion after the first pass, defined by eTICI score of 2c or greater. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion

Outcome measures

Outcome measures
Measure
SR Classic
n=233 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=680 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=529 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Percentage of Subjects Achieved eTICI 2c or Greater on First Pass (Adjudicated by the Core Lab)
110 Participants
309 Participants
193 Participants

SECONDARY outcome

Timeframe: 90 Days (±14 days)

Percentage of subjects with an excellent functional outcome of mRS of 0-1 at Day 90 (± 14). Modified Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is a score ranging from 0-6 with the following degree of disability: 0 = No symptoms at all, no limitations and no symptoms; 1 = No significant disability, 2 = Slight disability; 3 = Moderate disability; 4 = Moderate severe disability, 5 = Severe disability; 6= Death. The lower mRS Score indicates less disability.

Outcome measures

Outcome measures
Measure
SR Classic
n=237 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=666 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=506 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Percentage of Subjects With an Excellent Functional Outcome at Day 90
112 Participants
264 Participants
209 Participants

SECONDARY outcome

Timeframe: Discharge/ Day 5-7 (Whichever is earlier)

Percentage of subjects with an "early response" at Discharge/Day5-7 (whichever is earlier) defined as a NIHSS drop of ≥10 points from baseline or NIHSS score of 0 or 1. NIHSS (National Institutes of Health Stroke Scale) is an assessment to objectively quantify the impairment caused by a stroke. It is composed of 11 items, each of which scores a specific ability. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.

Outcome measures

Outcome measures
Measure
SR Classic
n=236 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=646 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=507 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Percentage of Subjects With an "Early Response" Defined by NIHSS Score
156 Participants
376 Participants
294 Participants

SECONDARY outcome

Timeframe: Day 90 (±14 days)

Population: The analysis population is based on availability of the self reported data

The Euro Quality of Life Questionnaire - 5 Level 5D Version (EQ5D5L) is composed of 5 dimensions- mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is evaluated by the subject on 5 level scale: no problems, slight problems, moderate problems, severe problems and extreme problems. The outcome reported shows severe and extreme levels were combined and only 4 levels are reported.

Outcome measures

Outcome measures
Measure
SR Classic
n=182 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=492 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=384 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Quality of Life at Day 90 Based on EQ5D5L Score
Pain/Discomfort: · No Problems
110 Participants
261 Participants
205 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Self-care: · No Problems
116 Participants
293 Participants
227 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Self-care: · Slight Problems
30 Participants
70 Participants
68 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Usual Activities · Moderate Problems
26 Participants
77 Participants
61 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Pain/Discomfort: · Slight Problems
50 Participants
124 Participants
99 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Pain/Discomfort: · Moderate Problems
20 Participants
78 Participants
59 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Pain/Discomfort: · Severe/Extreme Problems
2 Participants
28 Participants
21 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Anxiety/Depression: · No Problems
118 Participants
253 Participants
201 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Anxiety/Depression: · Slight Problems
41 Participants
125 Participants
107 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Anxiety/Depression: · Moderate Problems
11 Participants
85 Participants
46 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Anxiety/Depression: · Severe/Extreme Problems
12 Participants
26 Participants
29 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Mobility: · No Problems
103 Participants
247 Participants
187 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Mobility: · Slight Problems
36 Participants
94 Participants
77 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Mobility: · Moderate Problems
22 Participants
68 Participants
56 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Mobility: · Severe/Extreme Problems
21 Participants
83 Participants
64 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Self-care: · Moderate Problems
19 Participants
53 Participants
38 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Self-care: · Severe/Extreme Problems
17 Participants
76 Participants
51 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Usual Activities · No Problems
95 Participants
212 Participants
154 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Usual Activities · Slight Problems
44 Participants
107 Participants
96 Participants
Quality of Life at Day 90 Based on EQ5D5L Score
Usual Activities · Severe/Extreme Problems
17 Participants
96 Participants
73 Participants

SECONDARY outcome

Timeframe: At the time of procedure, after the first pass, and at the end of the procedure

Population: Subjects with available 90 Day core lab imaging data

This outcome reports percentage of subjects who achieved eTICI 2b50, eTICI 2b67, eTICI 2c,or eTICI 3 on first pass after primary technique used and at the end of the endovascular procedure. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion

Outcome measures

Outcome measures
Measure
SR Classic
n=245 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=692 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=544 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
At the End of Procedure · eTICI 2b50
2 Participants
38 Participants
36 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
After First Pass · eTICI 0, 1, or 2a
66 Participants
179 Participants
200 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
After First Pass · eTICI 2b50
16 Participants
55 Participants
52 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
After First Pass · eTICI 2b67
41 Participants
137 Participants
84 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
After First Pass · eTICI 2c
31 Participants
149 Participants
105 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
After First Pass · eTICI 3
79 Participants
160 Participants
88 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
At the End of Procedure · eTICI 0, 1, or 2a
7 Participants
33 Participants
17 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
At the End of Procedure · eTICI 2b67
65 Participants
172 Participants
134 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
At the End of Procedure · eTICI 2c
57 Participants
238 Participants
200 Participants
Percentage of Subjects Achieved eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 on First Pass After Primary Technique Used and at the End of Endovascular Procedure.
At the End of Procedure · eTICI 3
114 Participants
211 Participants
157 Participants

SECONDARY outcome

Timeframe: During the procedure, from groin puncture to after the first pass

This outcome measures overall time (in minutes) observed from groin puncture to the specific eTICI reperfusion score at end of first pass for treatment of target occlusion. Each subject can only be in one eTICI category and therefore they are mutually exclusive. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion

Outcome measures

Outcome measures
Measure
SR Classic
n=167 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=498 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=326 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
eTICI 2b67
25.68 Minutes
Standard Deviation 17.0
28.85 Minutes
Standard Deviation 16.5
19.24 Minutes
Standard Deviation 12.3
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
eTICI 2b50
21.94 Minutes
Standard Deviation 8.5
23.31 Minutes
Standard Deviation 12.4
20.14 Minutes
Standard Deviation 13.9
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
eTICI 2c
22.77 Minutes
Standard Deviation 11.2
27.59 Minutes
Standard Deviation 13.7
18.61 Minutes
Standard Deviation 14.0
Time From Groin Puncture to Achieve eTICI 2b50, eTICI 2b67, eTICI 2c, or eTICI 3 After the First Pass
eTICI 3
23.19 Minutes
Standard Deviation 13.6
27.17 Minutes
Standard Deviation 16.0
20.40 Minutes
Standard Deviation 10.7

SECONDARY outcome

Timeframe: Time of procedure, from groing puncture to revascularization

Population: Limited to subjects who achieved eTICI 2c or 3

This outcome measures the overall time (in minutes) observed from groin puncture to final reperfusion of eTICI 2c or 3 for treatment of target occlusion. Independent Imaging Core Lab adjudicated the outcome using the Expanded Treatment in Cerebral Infarction (eTICI) scale. The higher eTICI score indicates successful revascularization. The Expanded TICI (eTICI) Perfusion Score Categories are: * 0: Equivalent to no reperfusion or 0% filling of the downstream territory * 1: Reflects thrombus reduction without any reperfusion of distal arteries * 2a: Reperfusion in less than half or 1-49% of the territory * 2b50: 50-66% reperfusion * 2b67: 67-89% reperfusion * 2c: 90-99% reperfusion * 3: Complete or 100% reperfusion

Outcome measures

Outcome measures
Measure
SR Classic
n=145 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=414 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=313 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Overall Time From Groin Puncture to Achieve Final Reperfusion of eTICI 2c or 3
29.17 Minutes
Standard Deviation 19.3
31.26 Minutes
Standard Deviation 17.5
27.05 Minutes
Standard Deviation 19.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 Days (+/- 14 Days)

Population: The analysis population for each variable determined by available imaging data from the Core Lab

Prespecified safety outcome measures include all-cause mortality and stroke-related mortality up to 90 days (±14), device and/or procedure related SAEs up to 90 Days (±14), neurological deterioration at 24 hours post procedure, embolization to new territory adjudicated by core lab. and neurological deterioration at 24 hours post-procedure to 48 hours

Outcome measures

Outcome measures
Measure
SR Classic
n=247 Participants
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=697 Participants
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=548 Participants
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Safety Outcomes
Symptomatic ICH up to 48 hrs post-procedure
5 Participants
15 Participants
14 Participants
Safety Outcomes
All-cause Mortality at 90 days (±14 days)
28 Participants
105 Participants
76 Participants
Safety Outcomes
Stroke-related Mortality at 90 days (±14 days)
19 Participants
63 Participants
38 Participants
Safety Outcomes
Device and/or procedure related SAEs at 90 days (±14 days)
16 Participants
40 Participants
23 Participants
Safety Outcomes
Embolization to New Territory during procedure (Core Lab)
2 Participants
6 Participants
3 Participants
Safety Outcomes
Neurological Deterioration (4 or greater increase in NIHSS) up to 48 hrs post-procedure
13 Participants
52 Participants
47 Participants
Safety Outcomes
Access Site Complications up to 48 hrs post-procedure
3 Participants
10 Participants
2 Participants

Adverse Events

SR Classic

Serious events: 69 serious events
Other events: 26 other events
Deaths: 28 deaths

SR Combination

Serious events: 220 serious events
Other events: 44 other events
Deaths: 105 deaths

Direct Aspiration

Serious events: 176 serious events
Other events: 27 other events
Deaths: 76 deaths

Serious adverse events

Serious adverse events
Measure
SR Classic
n=247 participants at risk
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=697 participants at risk
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=548 participants at risk
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
General disorders
Infusion site extravasation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Blood and lymphatic system disorders
Anaemia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.86%
6/697 • Number of events 6 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Blood and lymphatic system disorders
Hyperchromic anaemia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Acute left ventricular failure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Acute myocardial infarction
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.57%
4/697 • Number of events 4 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Atrial fibrillation
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.73%
4/548 • Number of events 4 • 90 Days (+/- 14 Days)
Cardiac disorders
Bradycardia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiac arrest
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.72%
5/697 • Number of events 6 • 90 Days (+/- 14 Days)
0.91%
5/548 • Number of events 5 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiac failure
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiac failure acute
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiac failure congestive
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiac ventricular thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.73%
4/548 • Number of events 4 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiogenic shock
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiomyopathy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiopulmonary failure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.57%
4/697 • Number of events 4 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Cardiorenal syndrome
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Coronary artery disease
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Cardiac disorders
Coronary artery stenosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Degenerative mitral valve disease
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Myocardial infarction
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Myocardial ischaemia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Myocarditis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Pericardial effusion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Stress cardiomyopathy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Supraventricular tachycardia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Cardiac disorders
Ventricular fibrillation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Ventricular tachycardia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Congenital, familial and genetic disorders
Atrial septal defect
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Ear and labyrinth disorders
Vertigo
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Colitis ischaemic
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Dysphagia
1.6%
4/247 • Number of events 4 • 90 Days (+/- 14 Days)
1.0%
7/697 • Number of events 7 • 90 Days (+/- 14 Days)
2.2%
12/548 • Number of events 12 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Erosive duodenitis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.55%
3/548 • Number of events 3 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Mallory-Weiss syndrome
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Retroperitoneal haematoma
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Retroperitoneal haemorrhage
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
Condition aggravated
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
Death
0.00%
0/247 • 90 Days (+/- 14 Days)
1.0%
7/697 • Number of events 7 • 90 Days (+/- 14 Days)
1.8%
10/548 • Number of events 10 • 90 Days (+/- 14 Days)
General disorders
General physical health deterioration
0.00%
0/247 • 90 Days (+/- 14 Days)
0.57%
4/697 • Number of events 4 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
General disorders
Hyperthermia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
Multiple organ dysfunction syndrome
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
General disorders
Pyrexia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
General disorders
Systemic inflammatory response syndrome
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
Vascular stent stenosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
General disorders
Vascular stent thrombosis
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Hepatobiliary disorders
Cholangitis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Hepatobiliary disorders
Ischaemic hepatitis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Immune system disorders
Hypersensitivity
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Clostridium difficile colitis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Clostridium difficile infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Infections and infestations
Corona virus infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.91%
5/548 • Number of events 5 • 90 Days (+/- 14 Days)
Infections and infestations
Endocarditis
1.2%
3/247 • Number of events 3 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Infections and infestations
Enterococcal infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Pneumonia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
1.9%
13/697 • Number of events 13 • 90 Days (+/- 14 Days)
1.3%
7/548 • Number of events 7 • 90 Days (+/- 14 Days)
Infections and infestations
Pneumonia escherichia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Pneumonia viral
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Infections and infestations
Postoperative wound infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Respiratory tract infection
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Sepsis
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.72%
5/697 • Number of events 5 • 90 Days (+/- 14 Days)
1.3%
7/548 • Number of events 7 • 90 Days (+/- 14 Days)
Infections and infestations
Septic shock
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.72%
5/697 • Number of events 5 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Infections and infestations
Staphylococcal infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Infections and infestations
Systemic candida
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Infections and infestations
Urinary tract infection
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
1.3%
7/548 • Number of events 7 • 90 Days (+/- 14 Days)
Infections and infestations
Urosepsis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Brain herniation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Cerebral artery restenosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site haematoma
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site haemorrhage
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.72%
5/697 • Number of events 5 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Investigations
NIH stroke scale score increased
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Investigations
Troponin increased
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Adult failure to thrive
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Electrolyte imbalance
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Reproductive system and breast disorders
Dysfunctional uterine bleeding
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Hyponatraemia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Metabolism and nutrition disorders
Malnutrition
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Aphasia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Basal ganglia infarction
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Brain compression
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Brain oedema
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
1.1%
8/697 • Number of events 8 • 90 Days (+/- 14 Days)
4.0%
22/548 • Number of events 22 • 90 Days (+/- 14 Days)
Nervous system disorders
Carotid artery aneurysm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Carotid artery dissection
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Carotid artery occlusion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Carotid artery stenosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebellar infarction
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebellar stroke
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral artery embolism
3.2%
8/247 • Number of events 8 • 90 Days (+/- 14 Days)
0.72%
5/697 • Number of events 5 • 90 Days (+/- 14 Days)
0.73%
4/548 • Number of events 4 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral artery occlusion
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 3 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral artery perforation
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral circulatory failure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral haemorrhage
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral infarction
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
1.1%
8/697 • Number of events 8 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral ischaemia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebrovascular accident
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
1.6%
11/697 • Number of events 11 • 90 Days (+/- 14 Days)
1.3%
7/548 • Number of events 7 • 90 Days (+/- 14 Days)
Nervous system disorders
Depressed level of consciousness
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Dizziness
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Embolic stroke
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Encephalopathy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Epilepsy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Haemorrhage intracranial
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
2.2%
15/697 • Number of events 15 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Nervous system disorders
Haemorrhagic transformation stroke
1.2%
3/247 • Number of events 3 • 90 Days (+/- 14 Days)
0.57%
4/697 • Number of events 4 • 90 Days (+/- 14 Days)
2.4%
13/548 • Number of events 13 • 90 Days (+/- 14 Days)
Nervous system disorders
Headache
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Hemiplegia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Hydrocephalus
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Hypoaesthesia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Intracranial aneurysm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Intracranial artery dissection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Intracranial mass
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Intracranial pressure increased
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Ischaemic stroke
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.55%
3/548 • Number of events 3 • 90 Days (+/- 14 Days)
Nervous system disorders
Monoplegia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Neurological decompensation
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
1.6%
9/548 • Number of events 9 • 90 Days (+/- 14 Days)
Nervous system disorders
Neurological symptom
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Seizure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Nervous system disorders
Stroke in evolution
4.0%
10/247 • Number of events 10 • 90 Days (+/- 14 Days)
2.7%
19/697 • Number of events 19 • 90 Days (+/- 14 Days)
2.4%
13/548 • Number of events 13 • 90 Days (+/- 14 Days)
Nervous system disorders
Subarachnoid haemorrhage
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.86%
6/697 • Number of events 6 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Transient ischaemic attack
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Vasogenic cerebral oedema
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Product Issues
Device occlusion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Psychiatric disorders
Delirium
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Psychiatric disorders
Mental status changes
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Psychiatric disorders
Suicidal ideation
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Acute kidney injury
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.55%
3/548 • Number of events 3 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Chronic kidney disease
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Renal artery occlusion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Renal failure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Renal tubular necrosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Reproductive system and breast disorders
Prostatic haemorrhage
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
1.0%
7/697 • Number of events 7 • 90 Days (+/- 14 Days)
2.4%
13/548 • Number of events 13 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 2 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/247 • 90 Days (+/- 14 Days)
1.3%
9/697 • Number of events 9 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
1.1%
6/548 • Number of events 6 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Respiratory failure
2.0%
5/247 • Number of events 5 • 90 Days (+/- 14 Days)
1.1%
8/697 • Number of events 8 • 90 Days (+/- 14 Days)
2.2%
12/548 • Number of events 12 • 90 Days (+/- 14 Days)
Social circumstances
Disability
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Endarterectomy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Endotracheal intubation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Intestinal resection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Medical device implantation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Medical device removal
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Surgery
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Thyroidectomy
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Surgical and medical procedures
Vena cava filter insertion
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Aortic stenosis
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Aortic thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Arteriosclerosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Arteriovenous fistula
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Deep vein thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.91%
5/548 • Number of events 5 • 90 Days (+/- 14 Days)
Vascular disorders
Femoral artery aneurysm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Haematoma
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Haemodynamic instability
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Vascular disorders
Hypertension
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Hypertensive crisis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Hypertensive emergency
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Hypotension
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Vascular disorders
Orthostatic hypotension
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Peripheral artery thrombosis
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Peripheral ischaemia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Vascular disorders
Reperfusion injury
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Shock
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Thrombophlebitis superficial
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Vascular dissection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Vasospasm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Vessel perforation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)

Other adverse events

Other adverse events
Measure
SR Classic
n=247 participants at risk
SR (Trevo®\]) + BGC (FlowGate2\] or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
SR Combination
n=697 participants at risk
SR (Trevo) + Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or SR (Trevo) + Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2 or Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Direct Aspiration
n=548 participants at risk
Asp Cath (AXS Catalyst DAC, Vecta) ± Pump + LS (AXS Infinity LS, AXS Infinity LS Plus) or Asp Cath (AXS Catalyst DAC) ± Pump + BGC (FlowGate2, Merci) Mechanical Thrombectomy: Treatment of LVO with mechanical thrombectomy
Cardiac disorders
Acute myocardial infarction
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Bradycardia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Cardiac disorders
Supraventricular tachycardia
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Ear and labyrinth disorders
Tinnitus
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Gastrointestinal disorders
Vomiting
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
General physical health deterioration
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
General disorders
Infusion site extravasation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
General disorders
Vessel puncture site thrombosis
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Infections and infestations
Infection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Periorbital haematoma
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site bruising
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site complication
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site discharge
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site haematoma
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site haemorrhage
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Carotid artery perforation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral artery embolism
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 3 • 90 Days (+/- 14 Days)
0.73%
4/548 • Number of events 4 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral artery perforation
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral haemorrhage
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral infarction
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Cerebral vasoconstriction
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Haemorrhage intracranial
2.4%
6/247 • Number of events 6 • 90 Days (+/- 14 Days)
0.43%
3/697 • Number of events 4 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Haemorrhagic transformation stroke
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Intracranial artery dissection
0.40%
1/247 • Number of events 1 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Neurological decompensation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.36%
2/548 • Number of events 2 • 90 Days (+/- 14 Days)
Nervous system disorders
Seizure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Nervous system disorders
Stroke in evolution
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Nervous system disorders
Subarachnoid haemorrhage
2.0%
5/247 • Number of events 5 • 90 Days (+/- 14 Days)
1.9%
13/697 • Number of events 13 • 90 Days (+/- 14 Days)
0.55%
3/548 • Number of events 3 • 90 Days (+/- 14 Days)
Psychiatric disorders
Agitation
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Acute kidney injury
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Renal and urinary disorders
Renal failure
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/247 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Arteriovenous fistula
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Haematoma
1.2%
3/247 • Number of events 3 • 90 Days (+/- 14 Days)
0.00%
0/697 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Hypotension
0.81%
2/247 • Number of events 2 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.18%
1/548 • Number of events 1 • 90 Days (+/- 14 Days)
Vascular disorders
Peripheral ischaemia
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Vascular dissection
0.00%
0/247 • 90 Days (+/- 14 Days)
0.14%
1/697 • Number of events 1 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)
Vascular disorders
Vasospasm
0.00%
0/247 • 90 Days (+/- 14 Days)
0.29%
2/697 • Number of events 2 • 90 Days (+/- 14 Days)
0.00%
0/548 • 90 Days (+/- 14 Days)

Additional Information

Sr. Clinical Project Manger

Stryker Neurovascular

Phone: 510-413-2500

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place