Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
Purpose
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.
Condition
- Aneurysm, Brain
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts 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 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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Single Arm | Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Penumbra Inc.