Clinical Trial TitleSURF: A prospective, multicenter study assessing the embolization of intracranial aneurysms using WAVE™ Extra Soft coils, a part of the Penumbra SMART COIL® System.
National Clinical Trial Number:NCT04106583
Clinical Trial Protocol Description:
This is a research registry that follows people who get the SMART COIL System, including the WAVE Extra Soft Coils (device) as part of their aneurysm treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age.
- Are having embolization of intracranial aneurysms.
- WAVE Extra Soft Coil is the 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.
You will be excluded from the study if any of the following criteria apply to you:
- Have a life expectancy less than 1 year.
- Have previously enrolled in the SURF Study.
- Have known multiple intracranial aneurysms requiring treatment during index procedure.
- Are 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 this study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Clinical Trial Investigator
Michael Chen, MD
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612