Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

Completed

Brief 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Efficacy: Adequate Occlusion	Through Study Completion, An Average of 1 Year	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.
Safety: Serious Adverse Events (SAEs)	Up to 24 Hours Post-Procedure	The primary safety endpoints are SAEs within 24 hours post-procedure
Safety: Device-Related SAE	Through Discharge, up to 7 Days Post-Procedure	Device-related SAE up to 7 days or discharge

Secondary Outcome Measures

Name	Time	Method
Efficacy: Occlusion Rate	Immediate Post-Procedure	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
Efficacy: Retreatment Rate	Through Study Completion, An Average of 1 Year	Retreatment rate at final follow-up
Efficacy: Aneurysm Occlusion Raymond I	Through Study Completion, An Average of 1 Year	Raymond-Roy Class grading ranges I to III higher values represent a worse outcome.
Efficacy: Aneurysm Recanalization or Progressive Thrombosis	From Immediate Post Procedure Through Study Completion, An Average of 1 Year	Aneurysm recanalization or progressive thrombosis from post procedure to final follow-up
Safety: Major Ipsilateral Stroke	Through Study Completion, An Average of 1 Year	Occurrence of Major Ipsilateral Stroke
Safety: Device-Related SAE	Through Study Completion, An Average of 1 Year	Device related SAE at final follow-up
Safety: Morbidity and Mortality	Through Study Completion, An Average of 1 Year	All-cause morbidity and mortality at final follow-up

Locations (43): 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
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Southeast Health Medical Center
🇺🇸Dothan, Alabama, United States