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 Type
OBSERVATIONAL
Enrollment
572
WAVE, as part of the SMART COIL System
Efficacy: Adequate Occlusion
Adequate occlusion defined as Raymond-Roy Class I and II at final follow-up Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Time frame: Through Study Completion, An Average of 1 Year
Safety: Serious Adverse Events (SAEs)
The primary safety endpoints are SAEs within 24 hours post-procedure
Time frame: Up to 24 Hours Post-Procedure
Safety: Device-Related SAE
Device-related SAE up to 7 days or discharge
Time frame: Through Discharge, up to 7 Days Post-Procedure
Efficacy: Occlusion Rate
Immediate post-procedure occlusion rates: Class 1 - Complete occlusion Class 2 - Residual neck Class 3 - Residual aneurysm The classification of angiographic results was adopted from Roy, Milot, and Raymond. Stroke 2001;32:1998-2004
Time frame: Immediate Post-Procedure
Efficacy: Retreatment Rate
Retreatment rate at final follow-up
Time frame: Through Study Completion, An Average of 1 Year
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Time frame: Immediate Post-Treatment
Efficacy: Aneurysm Occlusion Raymond I
Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Time frame: Through Study Completion, An Average of 1 Year
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Southeast Health Medical Center
Dothan, Alabama, United States
Banner UMC Tucson
Tucson, Arizona, United States
Sharp Grossmont
La Mesa, California, United States
Los Robles
Thousand Oaks, California, United States
HRI - Swedish
Englewood, Colorado, United States
St. Anthony's Hospital
Lakewood, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
University of Miami (Jackson Memorial)
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Morton Plant
Tampa, Florida, United States
...and 33 more locations
Efficacy: Aneurysm Recanalization or Progressive Thrombosis
Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up
Time frame: From Immediate Post Procedure Through Study Completion, An Average of 1 Year
Safety: Major Ipsilateral Stroke
Occurrence of Major Ipsilateral Stroke
Time frame: Through Study Completion, An Average of 1 Year
Safety: Device-Related SAE
Device related SAE at final follow-up
Time frame: Through Study Completion, An Average of 1 Year
Safety: Morbidity and Mortality
All-cause morbidity and mortality at final follow-up
Time frame: Through Study Completion, An Average of 1 Year