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

Completed

Conditions studied: Aneurysm, Brain

In brief

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.

Key facts

Study ID

NCT04106583

Run by

Penumbra Inc.

People needed

572

Starts

2019-11-05

Expected to finish

2023-08-02

Last updated by the study team

2025-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Southeast Health Medical Center — Dothan, Alabama, United States
• Banner UMC Tucson — Tucson, Arizona, United States
• Sharp Grossmont — La Mesa, California, United States
• Los Robles — Thousand Oaks, California, United States
• HRI - Swedish — Englewood, Colorado, United States
• St. Anthony's Hospital — Lakewood, Colorado, United States
• Yale New Haven — New Haven, Connecticut, United States
• University of Miami (Jackson Memorial) — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Morton Plant — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Amita Health — Joliet, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Metro Health — Wyoming, Michigan, United States
• SSM Health Care — Bridgeton, Missouri, United States
• Northwell Health — Manhasset, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• Mercy St. Vincent — Toledo, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• Geisinger Medical Center — Danville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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