Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System

Conditions
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Aneurysm, Brain

Intervention / Treatment
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* Device: WAVE, as part of the SMART COIL System


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System | Device: WAVE, as part of the SMART COIL System<br>* WAVE, as part of the SMART COIL System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through Study Completion, An Average of 1 Year | 
| Safety: Serious Adverse Events (SAEs) | SAEs within 24 hours post-procedure | Up to 24 Hours Post-Procedure | 
| Safety: Device-Related SAE | Device-related SAE up to 7 days or discharge | Through Discharge, up to 7 Days Post-Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Occlusion rate | Immediate post-procedure occlusion rates | Immediate Post-Procedure | 
| Efficacy: Retreatment Rate | Retreatment rate at final follow-up | Through Study Completion, An Average of 1 Year | 
| Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | Immediate Post-Treatment | 
| Efficacy: Aneurysm Occlusion Raymond I | Raymond-Roy Class grading ranges I to III higher values represent a worse outcome. | Through Study Completion, An Average of 1 Year | 
| Efficacy: Aneurysm Recanalization or Progressive Thrombosis | Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up | From Immediate Post Procedure Through Study Completion, An Average of 1 Year | 
| Safety: Major Ipsilateral Stroke | Occurrence of Major Ipsilateral Stroke | Through Study Completion, An Average of 1 Year | 
| Safety: Device-Related SAE | Device related SAE at final follow-up | Through Study Completion, An Average of 1 Year | 
| Safety: All-cause Morbidity and Mortality | All-cause morbidity and mortality at final follow-up | Through Study Completion, An Average of 1 Year |