N/A
N=572
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
Aneurysm, Brain
Bottom Line
View on ClinicalTrials.gov: NCT04106583 ↗Enrolled (actual)
572
Serious AEs
24.5%
Results posted
Mar 2025
Primary outcome: Primary: Efficacy: Adequate Occlusion — 366 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- WAVE, as part of the SMART COIL System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Adequate Occlusion |
366 | — |
| PRIMARY Safety: Serious Adverse Events (SAEs) |
53 | — |
| PRIMARY Safety: Device-Related SAE |
6 | — |
| SECONDARY Efficacy: Occlusion Rate |
361; 137; 72 | — |
| SECONDARY Efficacy: Retreatment Rate |
45 | — |
| SECONDARY Efficacy: Aneurysm Occlusion Raymond I |
313 | — |
| SECONDARY Efficacy: Aneurysm Occlusion Raymond I |
313 | — |
| SECONDARY Efficacy: Aneurysm Recanalization or Progressive Thrombosis |
110; 235; 50 | — |
| SECONDARY Safety: Major Ipsilateral Stroke |
10 | — |
| SECONDARY Safety: Device-Related SAE |
6 | — |
| SECONDARY Safety: Morbidity and Mortality |
123 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04106583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.