CompletedNot Applicable

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

United States572 participantsStarted 2019-11-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Efficacy: Adequate Occlusion

Timeframe: Through Study Completion, An Average of 1 Year

Safety: Serious Adverse Events (SAEs)

Timeframe: Up to 24 Hours Post-Procedure

Safety: Device-Related SAE

Timeframe: Through Discharge, up to 7 Days Post-Procedure

Trial details

NCT IDNCT04106583

SponsorPenumbra Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-08-02

Results submitted2024-11-21