Aneurysm, Brain
Conditions
Brief summary
The objective of this study is to demonstrate the safety and efficacy of the Penumbra SMART COIL® System, including the WAVE™ Extra Soft Coils (WAVE) as a fill and finish coil, in the treatment of intracranial aneurysms. Imaging will be analyzed by an independent core lab to assess aneurysm occlusion rates and perform a comparative analysis between imaging modalities.
Interventions
DEVICEWAVE, as part of the SMART COIL System
WAVE, as part of the SMART COIL System
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient age ≥ 18 years * Patient having embolization of intracranial aneurysms * WAVE Extra Soft Coil is final finishing coil * Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted * Informed consent obtained per Institutional Review Board/Ethics Committee (IRB/EC) requirements
Exclusion criteria
* Life expectancy less than 1 year * Patient previously enrolled in the SURF Study * Known multiple intracranial aneurysms requiring treatment during index procedure * Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate * Participation in an interventional drug or device study that may confound the results of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Adequate Occlusion | Through Study Completion, An Average of 1 Year | 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. |
| Safety: Serious Adverse Events (SAEs) | Up to 24 Hours Post-Procedure | The primary safety endpoints are SAEs within 24 hours post-procedure |
| Safety: Device-Related SAE | Through Discharge, up to 7 Days Post-Procedure | Device-related SAE up to 7 days or discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Aneurysm Recanalization or Progressive Thrombosis | From Immediate Post Procedure Through Study Completion, An Average of 1 Year | Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up |
| Safety: Major Ipsilateral Stroke | Through Study Completion, An Average of 1 Year | Occurrence of Major Ipsilateral Stroke |
| Efficacy: Occlusion Rate | Immediate Post-Procedure | 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 |
| Safety: Morbidity and Mortality | Through Study Completion, An Average of 1 Year | All-cause morbidity and mortality at final follow-up |
| Safety: Device-Related SAE | Through Study Completion, An Average of 1 Year | Device related SAE at final follow-up |
| Efficacy: Retreatment Rate | Through Study Completion, An Average of 1 Year | Retreatment rate at final follow-up |
| Efficacy: Aneurysm Occlusion Raymond I | Immediate Post-Treatment | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. |
Countries
Canada, Germany, Italy, Spain, Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System | 572 |
| Total | 572 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 216 Participants |
| Age, Categorical Between 18 and 65 years | 356 Participants |
| Age, Continuous | 59.5 years STANDARD_DEVIATION 12.88 |
| Body Mass Index | 28.6 kg/m2 STANDARD_DEVIATION 7.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 79 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 389 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 57 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants |
| Race (NIH/OMB) Black or African American | 83 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 43 Participants |
| Race (NIH/OMB) White | 374 Participants |
| Sex: Female, Male Female | 415 Participants |
| Sex: Female, Male Male | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 36 / 572 |
| other Total, other adverse events | 20 / 572 |
| serious Total, serious adverse events | 140 / 572 |
Outcome results
Primary
Efficacy: Adequate Occlusion
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.
Time frame: Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 396 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Efficacy: Adequate Occlusion | 366 Participants |
Primary
Safety: Device-Related SAE
Device-related SAE up to 7 days or discharge
Time frame: Through Discharge, up to 7 Days Post-Procedure
Population: The analysis population (ITT) contains 567 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety: Device-Related SAE | 6 Participants |
Primary
Safety: Serious Adverse Events (SAEs)
The primary safety endpoints are SAEs within 24 hours post-procedure
Time frame: Up to 24 Hours Post-Procedure
Population: The analysis population (ITT) contains 572 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety: Serious Adverse Events (SAEs) | 53 Participants |
Secondary
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Time frame: Immediate Post-Treatment
Population: The analysis population (ITT) contains 570 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Efficacy: Aneurysm Occlusion Raymond I | 361 Participants |
Secondary
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Time frame: Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 396 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Efficacy: Aneurysm Occlusion Raymond I | 313 Participants |
Secondary
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up
Time frame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 395 evaluable participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Progressive Thrombosis | 110 Participants |
| Single Arm | Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Stable Raymond-Roy Occlusion | 235 Participants |
| Single Arm | Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Recanalization | 50 Participants |
Secondary
Efficacy: Occlusion Rate
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
Time frame: Immediate Post-Procedure
Population: The analysis population (ITT) contains 570 evaluable participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Arm | Efficacy: Occlusion Rate | Participants with Raymond-Roy Occlusion Class I | 361 Participants |
| Single Arm | Efficacy: Occlusion Rate | Participants with Raymond-Roy Occlusion Class II | 137 Participants |
| Single Arm | Efficacy: Occlusion Rate | Participants with Raymond-Roy Occlusion Class III | 72 Participants |
Secondary
Efficacy: Retreatment Rate
Retreatment rate at final follow-up
Time frame: Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 457 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Efficacy: Retreatment Rate | 45 Participants |
Secondary
Safety: Device-Related SAE
Device related SAE at final follow-up
Time frame: Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 572 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety: Device-Related SAE | 6 Participants |
Secondary
Safety: Major Ipsilateral Stroke
Occurrence of Major Ipsilateral Stroke
Time frame: Through Study Completion, An Average of 1 Year
Population: The analysis population (ITT) contains 572 evaluable participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety: Major Ipsilateral Stroke | 10 Participants |
Secondary
Safety: Morbidity and Mortality
All-cause morbidity and mortality at final follow-up
Time frame: Through Study Completion, An Average of 1 Year
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Single Arm | Safety: Morbidity and Mortality | 123 Participants |