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

ID#: NCT04106583

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: October 30, 2019

End Date: June 01, 2023

Contact Information:
Ravi Radhakrishnan
+1 404 519 7065
Michaella Corso
+1 510 995 2079
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.

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 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