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Clinical trialNCT04106583CompletedObservational

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

SponsorPenumbra Inc.Enrollment572Aneurysm, Brain
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

43 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Foothills Medical Center

    Calgary, Canada

  • University Health Network

    Toronto, Canada

Germany
  • Bremen-Mitte

    Bremen, Germany

  • Klinikum Chemnitz Ggmbh

    Chemnitz, Germany

  • Uksh - Campus Lübeck

    Lübeck, Germany

Italy
  • Maggiore Della Carità

    Novara, Italy

Spain
  • Vall D'Hebron

    Barcelona, Spain

  • Donostia

    San Sebastián, Spain

Switzerland
  • Universitätsspital Basel

    Basel, Switzerland

United States
  • 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

  • Morton Plant

    Tampa, Florida, United States

  • University of South Florida

    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

  • Brigham and Women'S Hospital

    Boston, Massachusetts, United States

  • Massachusetts General 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

  • Upenn

    Philadelphia, Pennsylvania, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, United States

  • Musc

    Charleston, South Carolina, United States

  • Greenville Memorial Hospital

    Greenville, South Carolina, United States

  • University of Tennessee Medical Center, Knoxville

    Knoxville, Tennessee, United States

  • Baylor University Medical Center

    Dallas, Texas, United States

3 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
5 Nov 2019
Primary completion
2 Aug 2023
Completion
2 Aug 2023
Last update posted
4 Mar 2025
Registered enrollment
572
Registry id
NCT04106583

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.