Status:
COMPLETED
Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
Lead Sponsor:
Penumbra Inc.
Conditions:
Aneurysm, Brain
Eligibility:
All Genders
18+ years
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 int...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 5 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
572 Patients enrolled
Trial Details
Trial ID
NCT04106583
Start Date
November 5 2019
End Date
August 2 2023
Last Update
March 4 2025
Active Locations (43)
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1
Southeast Health Medical Center
Dothan, Alabama, United States, 36301
2
Banner UMC Tucson
Tucson, Arizona, United States, 85719
3
Sharp Grossmont
La Mesa, California, United States, 91942
4
Los Robles
Thousand Oaks, California, United States, 91360