At a glance
ClinicalIndex Comparison RecordN/ACompleted· 995 enrolled
Drug / intervention
Penumbra Smart Coil +1 moredevice
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.
SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System
In Brief
A clinical study evaluating Penumbra Smart Coil and Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) for Intracranial Aneurysm. Completed, enrolled 995 participants across 72 sites in 2 countries.
Detailed Summary
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntracranial Aneurysm
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionDec 2019
TodayJul 2026
First PostedApr 6, 2016
Enrollment StartJun 3, 2016
Primary CompletionDec 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 10.2 years ago
Interventions
Penumbra Smart Coildevice
Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)device
Other Penumbra Coils available as standard of care