At a glance
ClinicalIndex Comparison RecordN/ACompleted· 572 enrolled
Drug / intervention
WAVE, as part of the SMART COIL Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter Study Assessing the Embolization of Intracranial Aneurysms Using WAVE™ Extra Soft Coils, a Part of the Penumbra SMART COIL® System
In Brief
An observational study evaluating WAVE, as part of the SMART COIL System for Aneurysm, Brain. Completed, enrolled 572 participants across 43 sites in 6 countries.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAneurysm, Brain
CountriesCanada, Germany, Italy, Spain, Switzerland, United States
Collaborators--
Timeline
N/ACompletedFinished
2020202120222023202420252026
First PostedSep 2019
Enrollment StartNov 2019
Primary CompletionAug 2023
TodayJul 2026
First PostedSep 27, 2019
Enrollment StartNov 5, 2019
Primary CompletionAug 2, 2023
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.8 years ago
Interventions
WAVE, as part of the SMART COIL Systemdevice
WAVE, as part of the SMART COIL System