Trial Outcomes & Findings for Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms (NCT NCT02179190)

NCT ID: NCT02179190

Last Updated: 2018-12-26

Results Overview

The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for \> 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 138 participants
• Primary outcome timeframe: 12 months, after device implant
• Results posted on: 2018-12-26

Participant Flow

Participant milestones

Measure	BARREL VRD The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Enrollment STARTED	138
Enrollment COMPLETED	127
Enrollment NOT COMPLETED	11
Index Procedure With Barrel VRD Attempt STARTED	127
Index Procedure With Barrel VRD Attempt COMPLETED	120
Index Procedure With Barrel VRD Attempt NOT COMPLETED	7
Follow-Up Post Barrel VRD Implanted STARTED	120
Follow-Up Post Barrel VRD Implanted COMPLETED	111
Follow-Up Post Barrel VRD Implanted NOT COMPLETED	9

Reasons for withdrawal

Measure	BARREL VRD The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Enrollment Exit Prior to Device Attempt	11
Index Procedure With Barrel VRD Attempt Did not receive Barrel VRD	7
Follow-Up Post Barrel VRD Implanted Death	3
Follow-Up Post Barrel VRD Implanted Withdrawal by Subject	3
Follow-Up Post Barrel VRD Implanted Physician Decision	2
Follow-Up Post Barrel VRD Implanted Lost to Follow-up	1

Baseline Characteristics

Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms

Baseline characteristics by cohort

Measure	BARREL VRD n=127 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Age, Continuous Mean ± Standard Deviation	60.4 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	91 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months, after device implant

Population: Participants implanted with the Barrel VRD

The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for > 24 hours) at any time during the follow-up period.

The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows:

0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale

Outcome measures

Measure	BARREL VRD n=127 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.	5 Participants

PRIMARY outcome

Timeframe: 12 months, after device implant

Population: Subjects treated with the Barrel VRD that completed the 12 month visit imaging

The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture

The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows:

Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.

Class 3: Residual aneurysm - opacification of the aneurysmal sac

Outcome measures

Measure	BARREL VRD n=106 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture	67 Participants

SECONDARY outcome

Timeframe: Index Procedure, Day 0

This secondary outcome measure provides the number of subjects successfully implanted with the Barrel VRD.

Outcome measures

Measure	BARREL VRD n=127 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Successfully Deployed Barrel VRD	120 Participants

SECONDARY outcome

Timeframe: 12 months, after device implant

Population: Outcomes are based on observed data (i.e., 106 participants with 12-month evaluable imaging). 21/127 participants did not have evaluable imaging at 1-Year.

This secondary outcome measure provides the count of participants treated with the Barrel VRD with Independent Core Laboratory aneurysm occlusion imaging evaluations of Complete Occlusion (Raymond Grade I) and Residual Aneurysm Neck (Raymond Grade II) at 12 months combined. Subjects with evidence of parent artery stenosis, retreatment, or rupture were not considered success.

Raymond Grade Scale

Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac.

Class 3: Residual aneurysm - opacification of the aneurysmal sac.

Outcome measures

Measure	BARREL VRD n=106 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months	75 Participants

SECONDARY outcome

Timeframe: 12 months, after device implant

Population: Outcomes are based on observed data, from 111 participants completed at 1-year and 3 participants with an mRS score of 6 (death) prior to 1 year.

This secondary outcome provides the count of participants treated with the Barrel device with a Modified Rankin Score of 0-2 at 12 months or no change from baseline.

The Modified Rankin Score is a scale for measuring general functionality as follows:

0: No symptoms at all

1. No significant disability despite symptoms; able to carry out all usual duties and activities

2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance

3. Moderate disability; requiring some help, but able to walk without assistance

4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance

5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention

6. Dead

Outcome measures

Measure	BARREL VRD n=114 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline	107 Participants

SECONDARY outcome

Timeframe: At 12 Months +/- 8 weeks

Population: Outcomes are based on observed data on 89 participants with evaluable angiographic data at 1 year. 38/127 participants did not have angiographic data at 1 year available for analysis.

This secondary measure provides the count of participants with parent artery stenosis per an independent core lab evaluation within the following ordinal groups: <25%, 25-50%, 51-75%, >75%.

Outcome measures

Measure	BARREL VRD n=89 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% In-Stent Stenosis at 12 Months < 25%	88 Participants
Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% In-Stent Stenosis at 12 Months 25-50%	1 Participants
Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% In-Stent Stenosis at 12 Months 51-75%	0 Participants
Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75% In-Stent Stenosis at 12 Months < 75%	0 Participants

SECONDARY outcome

Timeframe: 30 Days and 12 months +/- 8 weeks

This secondary outcome measure provides the combined number and percentage of subjects that died within 30 days or had a neurologic death within 12 months of receiving the study device.

Outcome measures

Measure	BARREL VRD n=127 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From the point of consent until participant exits the study at 1 year

Population: Subjects with an Attempted Barrel VRD Implant

This secondary outcome measure provides the count of participants reported with a Serious Device Related Adverse Events

Outcome measures

Measure	BARREL VRD n=127 Participants The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Number of Participants With Reported Device Related Serious Adverse Events	4 Participants

Adverse Events

BARREL VRD

Serious events: 44 serious events

Other events: 73 other events

Deaths: 3 deaths

Serious adverse events

Measure	BARREL VRD n=127 participants at risk The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
Blood and lymphatic system disorders Anaemia	3.1% 4/127 • Number of events 4 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Acute myocardial infarction	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Atrial fibrillation	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Atrioventricular block complete	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Cardiac failure congestive	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Cardio-respiratory arrest	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Cardiopulmonary failure	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Coronary artery disease	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Myocardial ischaemia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Haematochezia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Impaired gastric emptying	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Retroperitoneal haemorrhage	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Adverse drug reaction	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Catheter site haematoma	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Infections and infestations Pneumonia bacterial	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Infections and infestations Pneumonia	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Infections and infestations Urinary tract infection	2.4% 3/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Metabolism and nutrition disorders Hypernatraemia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Metabolism and nutrition disorders Hyponatraemia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Arthralgia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Neck Pain	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioma	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retroperitoneal cancer	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Brain oedema	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Carotid artery stenosis	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Cerebral infarction	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Convulsion	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Haemorrhage intracranial	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Hemiparesis	0.79% 1/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Hydrocephalus	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Ischaemic stroke	6.3% 8/127 • Number of events 8 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Migraine	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Status epilepticus	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Transient ischaemic attack	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Vertebral artery dissection	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Psychiatric disorders Mental status changes	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Renal and urinary disorders Glomerulonephritis rapidly progressive	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	2.4% 3/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.6% 2/127 • Number of events 4 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Surgical and medical procedures Spinal decompression	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Aneurysm	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Hypertensive emergency	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.

Other adverse events

Measure	BARREL VRD n=127 participants at risk The Barrel VRD was implanted as an adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries. BARREL VRD: The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
General disorders Catheter site haemorrhage	5.5% 7/127 • Number of events 7 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Headache	18.9% 24/127 • Number of events 27 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.5% 7/127 • Number of events 7 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Skin and subcutaneous tissue disorders Ecchymosis	7.1% 9/127 • Number of events 10 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Cardiac disorders Palpitations	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Ear and labyrinth disorders Tinnitus	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Eye disorders Diplopia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Eye disorders Eyelid ptosis	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Eye disorders Photopsia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Eye disorders Vision blurred	2.4% 3/127 • Number of events 4 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Eye disorders Visual impairment	2.4% 3/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Colitis	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 3/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Nausea	7.1% 9/127 • Number of events 9 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Oral mucosal blistering	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Rectal haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Gastrointestinal disorders Vomiting	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Asthenia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Catheter site haematoma	3.9% 5/127 • Number of events 5 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Catheter site inflammation	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Catheter site swelling	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Chest pain	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Drug intolerance	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Fatigue	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Injection site haemorrhage	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Local swelling	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
General disorders Thrombosis in device	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Infections and infestations Urinary tract infection	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Anaemia postoperative	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Ankle fracture	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Joint injury	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Procedural hypertension	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Procedural hypotension	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Procedural pain	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Radiation skin injury	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Injury, poisoning and procedural complications Wound secretion	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Metabolism and nutrition disorders Electrolyte imbalance	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Metabolism and nutrition disorders Fluid overload	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Metabolism and nutrition disorders Glucose tolerance impaired	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Arthritis	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Groin pain	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Joint effusion	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Muscle spasms	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Musculoskeletal and connective tissue disorders Muscular weakness	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Amnesia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Aphasia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Balance disorder	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Cerebral artery thrombosis	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Cerebral infarction	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Dizziness	5.5% 7/127 • Number of events 8 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Hypoaesthesia	1.6% 2/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Migraine	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Paraesthesia	1.6% 2/127 • Number of events 2 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Spondylitic myelopathy	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Syncope	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Transient ischaemic attack	2.4% 3/127 • Number of events 4 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Nervous system disorders Tremor	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Psychiatric disorders Disorientation	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Renal and urinary disorders Haematuria	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Renal and urinary disorders Urethral pain	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Skin and subcutaneous tissue disorders Alopecia	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Surgical and medical procedures Aneurysm repair	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Aneurysm	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Arterial stenosis	2.4% 3/127 • Number of events 3 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Intermittent claudication	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Thrombophlebitis	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.
Vascular disorders Vasospasm	0.79% 1/127 • Number of events 1 • Adverse Events were collected from the point of consent through the study exit at 12 months. The adverse event data reported by sites was adjudicated by a three member independent Clinical Events Committee (CEC). All data presented within this section has been CEC adjudicated. Adjudicable events met the following criteria: * Neurological cause adverse events with a corresponding worsening of NIHSS, * All Device related adverse events, * All Procedure related adverse events, * All SAEs, and * All Antiplatelet therapy related events.

Additional Information

Senior Manager, Clinical Project Management

Medtronic Plc

Phone: 949-680-1274

Email: darren.j.lacour@medtronic.com

Results disclosure agreements

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