Trial Outcomes & Findings for Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities (NCT NCT04106583)
NCT ID: NCT04106583
Last Updated: 2025-03-04
Results Overview
Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Recruitment status
COMPLETED
Target enrollment
572 participants
Primary outcome timeframe
Through Study Completion, An Average of 1 Year
Results posted on
2025-03-04
Participant Flow
Participant milestones
| Measure |
Single Arm
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Overall Study
STARTED
|
572
|
|
Overall Study
COMPLETED
|
494
|
|
Overall Study
NOT COMPLETED
|
78
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
47 out of 572 participants were not analyzed due to data not collected in the EU.
Baseline characteristics by cohort
| Measure |
Single Arm
n=572 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=572 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
356 Participants
n=572 Participants
|
|
Age, Categorical
>=65 years
|
216 Participants
n=572 Participants
|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 12.88 • n=572 Participants
|
|
Sex: Female, Male
Female
|
415 Participants
n=572 Participants
|
|
Sex: Female, Male
Male
|
157 Participants
n=572 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
79 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not collected in the EU.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
389 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not collected in the EU.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not collected in the EU.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
Asian
|
18 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
Black or African American
|
83 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
White
|
374 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=525 Participants • 47 out of 572 participants were not analyzed due to data not being collected in the EU. 27 out of the 525 analyzed participants were categorized as Race: "Other" - this number was added to 16 participants that were categorized under Race: "Unkown or Not Reported" in the Clinical Trial Report.
|
|
Body Mass Index
|
28.6 kg/m2
STANDARD_DEVIATION 7.69 • n=558 Participants • The analysis population (ITT) contains 558 evaluable participants.
|
PRIMARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 396 evaluable participants.
Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Outcome measures
| Measure |
Single Arm
n=396 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Adequate Occlusion
|
366 Participants
|
PRIMARY outcome
Timeframe: Up to 24 Hours Post-ProcedurePopulation: The analysis population (ITT) contains 572 evaluable participants.
The primary safety endpoints are SAEs within 24 hours post-procedure
Outcome measures
| Measure |
Single Arm
n=572 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Safety: Serious Adverse Events (SAEs)
|
53 Participants
|
PRIMARY outcome
Timeframe: Through Discharge, up to 7 Days Post-ProcedurePopulation: The analysis population (ITT) contains 567 evaluable participants.
Device-related SAE up to 7 days or discharge
Outcome measures
| Measure |
Single Arm
n=567 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Safety: Device-Related SAE
|
6 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-ProcedurePopulation: The analysis population (ITT) contains 570 evaluable participants.
Immediate post-procedure occlusion rates: Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004
Outcome measures
| Measure |
Single Arm
n=570 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Occlusion Rate
Participants with Raymond-Roy Occlusion Class I
|
361 Participants
|
|
Efficacy: Occlusion Rate
Participants with Raymond-Roy Occlusion Class II
|
137 Participants
|
|
Efficacy: Occlusion Rate
Participants with Raymond-Roy Occlusion Class III
|
72 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 457 evaluable participants.
Retreatment rate at final follow-up
Outcome measures
| Measure |
Single Arm
n=457 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Retreatment Rate
|
45 Participants
|
SECONDARY outcome
Timeframe: Immediate Post-TreatmentPopulation: The analysis population (ITT) contains 570 evaluable participants.
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Outcome measures
| Measure |
Single Arm
n=570 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Aneurysm Occlusion Raymond I
|
361 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 396 evaluable participants.
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Outcome measures
| Measure |
Single Arm
n=396 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Aneurysm Occlusion Raymond I
|
313 Participants
|
SECONDARY outcome
Timeframe: From Immediate Post Procedure Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 395 evaluable participants.
Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up
Outcome measures
| Measure |
Single Arm
n=395 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Stable Raymond-Roy Occlusion
|
235 Participants
|
|
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Recanalization
|
50 Participants
|
|
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Progressive Thrombosis
|
110 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 572 evaluable participants.
Occurrence of Major Ipsilateral Stroke
Outcome measures
| Measure |
Single Arm
n=572 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Safety: Major Ipsilateral Stroke
|
10 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 572 evaluable participants.
Device related SAE at final follow-up
Outcome measures
| Measure |
Single Arm
n=572 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Safety: Device-Related SAE
|
6 Participants
|
SECONDARY outcome
Timeframe: Through Study Completion, An Average of 1 YearPopulation: The analysis population (ITT) contains 572 evaluable participants. Morbidity through Final Follow-Up was reported in 106 out of 572 participants, and One-Year Mortality was reported in 36 out of 572 participants.
All-cause morbidity and mortality at final follow-up
Outcome measures
| Measure |
Single Arm
n=572 Participants
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Safety: Morbidity and Mortality
|
123 Participants
|
Adverse Events
Single Arm
Serious events: 140 serious events
Other events: 20 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Single Arm
n=572 participants at risk
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Cardiac disorders
Atrial fibrillation
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Cardiac disorders
Cardiac arrest
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Cardiac disorders
Cardiogenic shock
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Endocrine disorders
Diabetes insipidus
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Gastrointestinal disorders
Dysphagia
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Cardiac death
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Chest pain
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Death
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Infusion site haematoma
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Pyrexia
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Vascular stent occlusion
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Vascular stent thrombosis
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Immune system disorders
Anaphylactic reaction
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
COVID-19
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Klebsiella sepsis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Meningitis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Pneumonia
|
1.2%
7/572 • Number of events 7 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Pneumonia bacterial
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Sepsis
|
0.87%
5/572 • Number of events 5 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Septic shock
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Staphylococcal infection
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Infections and infestations
Urinary tract infection
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Aneurysm perforation
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Device placement issue
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Mental status changes postoperative
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Investigations
Angiogram cerebral abnormal
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Metabolism and nutrition disorders
Cerebral salt-wasting syndrome
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Aphasia
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Brain compression
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Brain oedema
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Brain stem infarction
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebellar microhaemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral artery embolism
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral artery thrombosis
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral infarction
|
0.87%
5/572 • Number of events 5 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cytotoxic oedema
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Embolic stroke
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Epilepsy
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Headache
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Hemiparesis
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Hydrocephalus
|
0.87%
5/572 • Number of events 5 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Intracranial aneurysm
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Ischaemic stroke
|
3.8%
22/572 • Number of events 24 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Loss of consciousness
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Migraine
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Neurological decompensation
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Posthaemorrhagic hydrocephalus
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Seizure
|
1.2%
7/572 • Number of events 8 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Stroke in evolution
|
0.87%
5/572 • Number of events 5 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Syncope
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Transient ischaemic attack
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
VIth nerve paralysis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Product Issues
Device dislocation
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Psychiatric disorders
Mental status changes
|
0.35%
2/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.87%
5/572 • Number of events 5 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Surgical and medical procedures
Aneurysm repair
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Surgical and medical procedures
Cerebral oedema management
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Surgical and medical procedures
Reduction of increased intracranial pressure
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Surgical and medical procedures
Surgery
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Surgical and medical procedures
Ventriculo-peritoneal shunt
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Aneurysm ruptured
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Aortic dissection
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Embolism
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Haematoma
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Hypertension
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Peripheral artery stenosis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Thrombosis
|
0.70%
4/572 • Number of events 4 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Vascular dissection
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Vasoconstriction
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Vasospasm
|
7.3%
42/572 • Number of events 46 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
Other adverse events
| Measure |
Single Arm
n=572 participants at risk
Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
|
|---|---|
|
General disorders
Pain
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
General disorders
Vascular stent thrombosis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Aneurysm perforation
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral artery embolism
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral infarction
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Cerebral reperfusion injury
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.35%
2/572 • Number of events 2 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Embolic stroke
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Nervous system disorders
Headache
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Haematoma
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Peripheral artery occlusion
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Thrombosis
|
0.17%
1/572 • Number of events 1 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
|
Vascular disorders
Vasospasm
|
0.52%
3/572 • Number of events 3 • Procedure, 7-day and/or Discharge, and final follow-up 1 year +/- 90 days
In this study, only device-related or procedure-related adverse events and all serious adverse events (SAEs) were collected from procedure through discharge. After discharge, only neurological SAEs were collected. Additional information for Symptomatic Intracranial Hemorrhage and Ischemic Stroke will be collected on Event of Interest case report forms (CRF).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER