A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms

NCT ID: NCT03642639

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

809 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-23

Study Completion Date

2025-06-12

Brief Summary

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A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Detailed Description

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A registry to collect real world data on the use of Cerenovus coils. The study will be a post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils

Conditions

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Aneurysms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coils

MICRUSFRAME and GALAXY coils

Group Type OTHER

MICRUSFRAME and GALAXY coils

Intervention Type DEVICE

MICRUSFRAME and GALAXY Coils

Interventions

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MICRUSFRAME and GALAXY coils

MICRUSFRAME and GALAXY Coils

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient is between 21 and 80 years of age
2. Patient has an intracranial saccular aneurysm, ruptured or unruptured, suitable for embolization with coils
3. Patient is able and willing to comply with protocol and follow-up requirements

Exclusion Criteria

1. Pre-planned staged procedure on unruptured aneurysm
2. More than one aneurysm requiring treatment during the course of study
3. Fusiform aneurysm
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cerenovus, Part of DePuy Synthes Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Reade De Leacy

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, New York

Osama Zaidat

Role: PRINCIPAL_INVESTIGATOR

Mercy Health St. Vincent Hospital

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

University of California Irvine

Orange, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Baptist Medical Center

Jacksonville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Memorial Health University

Savannah, Georgia, United States

Site Status

Rush University

Chicago, Illinois, United States

Site Status

University of Illinois

Chicago, Illinois, United States

Site Status

Javon Bea Hospital

Rockford, Illinois, United States

Site Status

Norton Healthcare

Louisville, Kentucky, United States

Site Status

Maine Medical Center

Scarborough, Maine, United States

Site Status

University of Massachusetts

Worcester, Massachusetts, United States

Site Status

St. Louis University

St Louis, Missouri, United States

Site Status

University of Buffalo

Buffalo, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Stony Brook University

Stony Brook, New York, United States

Site Status

Westchester Medical Center

Valhalla, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Mercy Health St. Vincent Medical Center

Toledo, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Greenville Health System

Greenville, South Carolina, United States

Site Status

Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, United States

Site Status

University of Tennessee

Knoxville, Tennessee, United States

Site Status

Texas Stroke Institute

Plano, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Algemeen Ziekenhuis Groeninge

Kortrijk, , Belgium

Site Status

Centre Hospitalier Universitaire d'Amiens Picardie

Amiens, , France

Site Status

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, , France

Site Status

Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille

Lille, , France

Site Status

Praticien Hospitalier Université de Lorraine

Nancy, , France

Site Status

Centre Hospitalier Regional Universitaire de Tours

Tours, , France

Site Status

Universitatsklinikum Schleswig Holstein

Lübeck, , Germany

Site Status

Galilee Hospital Naharyia

Nahariya, , Israel

Site Status

Ospedale Niguarda Ca' Granda

Milan, , Italy

Site Status

Policlinico Tor Vergata

Roma, , Italy

Site Status

Ospedale Cannizzaro

Sicily, , Italy

Site Status

Aichi Medical University Hospital

Aichi, , Japan

Site Status

Okayama University Hospital

Okayama, , Japan

Site Status

National Hospital Organization Osaka National Hospital

Osaka, , Japan

Site Status

Tominaga Hospital

Osaka, , Japan

Site Status

Kohnan Hospital

Sendai, , Japan

Site Status

Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital

Yokohama, , Japan

Site Status

Centro Hospitalar de Vila Nova de Gaia

Porto, , Portugal

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Hopitaux Universitaires de Geneve

Geneva, , Switzerland

Site Status

University Hospital Zurich

Zurich, , Switzerland

Site Status

Countries

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United States Belgium France Germany Israel Italy Japan Portugal Spain Switzerland

Other Identifiers

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CNV_2017_01

Identifier Type: -

Identifier Source: org_study_id