Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02729740|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Device: Penumbra SMART CoilTM Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SMART - A Prospective, Multicenter Study Assessing the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||August 2019|
Penumbra SMART CoilTM System
Coil technology has evolved considerably since the initial introduction of the GDC coil over 25 years ago. In recent history, coil development has mostly focused on the delivery system, or pusher technology, and detachment. The new Penumbra SMART Coil not only addresses improvements in the delivery system, but importantly incorporates new technology into the actual coil implant itself. Penumbra SMART technology enables an individual coil to become progressively softer as it is deployed, utilizes advanced materials to improve stretch resistance, and incorporates new processes to create accurate complex and helical shapes.
Device: Penumbra SMART CoilTM
Current coils available to physicians have three principal levels of softness, Standard, Soft and Extra Soft. A conventional coil currently has only one level of softness, derived from using smaller platinum filaments than a Standard coil to make Soft and Extra Soft coils. The level of softness of the Penumbra SMART Coil is determined not only by the diameter of the platinum filament, but also by a proprietary structural element inside the coil. This unique development enables the Penumbra SMART Coil to become progressively softer along the length of a single individual coil as it is being deployed.
Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care
- Ability to achieve adequate occlusion of the aneurysm sac by the SMART Coils [ Time Frame: 1-2 hrs within the procedure ]This a measure of the ability of the Smart Coils to occlude the aneurysm sac expressed as % occlusion of the volume.
- Number of times re-access with guidewire was required due to catheter kickout [ Time Frame: 1-2 hrs within the procedure ]
- Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: 1-2 hrs within the procedure ]
- Retreatment at follow-up [ Time Frame: One year from enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729740
Show 73 Study Locations