CompletedNot Applicable

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

United States, Canada, Germany572 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 range

18 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Aneurysm, Brain trials