Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Single Arm Single Arm - Patients with intracranial aneurysms treated with WAVE, as part of the Penumbra SMART COIL System
  • Device: WAVE, as part of the SMART COIL System
    WAVE, as part of the SMART COIL System

More Details

Status
Active, not recruiting
Sponsor
Penumbra Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.