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

NCT03642639 | Completed Results FDA Device

• 1 other identifier: CNV_2017_01
• Study Type: interventional
• Target: 723
• Locations: 10 countries
• Sites: 51

Brief Summary

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

Conditions

Aneurysms

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Adequate Occlusion (Modified Raymond-Roy I or II Classification) as Assessed by the Independent Core Lab Report of the Target Aneurysm at 1 Year Without Retreatment

  Number of participants who achieved adequate occlusion as assessed by the independent core lab report of the target aneurysm at 1 year without retreatment was reported. Adequate occlusion was defined as the achievement of a Modified Raymond-Roy classification of the aneurysm at 1 year without retreatment. Modified Raymond-Roy Classification scale is a system used to grade the angiographic results of endovascular treatment of brain aneurysms. Class I represents complete obliteration of the aneurysm. Class II indicates residual neck, defined as persistence of a portion of the original arterial wall defect without opacification of the aneurysmal wall. Class III is subdivided into IIIa and IIIb: Class IIIa refers to residual aneurysm filling with contrast opacification within the coil interstices, whereas Class IIIb denotes residual aneurysm filling with contrast outlining the aneurysm wall.

  At 1 year Post Procedure on Day 1

Secondary Outcomes (6)

• Packing Density Percentage (%) as Assessed by Independent Core Lab

  During procedure (Day 1)

• Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification)

  At 1 year Post Procedure on Day 1

• Recanalization Rate at 1 Year as Assessed by Independent Core Lab

  At 1 year Post Procedure on Day 1

• Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms

  From baseline (Day 1 of procedure) to 1 year post procedure on Day 1

• Number of Participants With Retreatment (Surgical or Endovascular)

  From baseline (Day 1 of procedure) to 1 year post procedure on Day 1

Study Arms (1)

Coils

OTHER

MICRUSFRAME and GALAXY coils

Device: MICRUSFRAME and GALAXY coils

Interventions

MICRUSFRAME and GALAXY coils DEVICE

MICRUSFRAME and GALAXY Coils

Coils

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pre-planned staged procedure on unruptured aneurysm
• More than one aneurysm requiring treatment during the course of study
• Fusiform aneurysm

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (51)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Baptist Medical Center

Jacksonville, Florida, 32207, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Memorial Health University

Savannah, Georgia, 31405, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

Javon Bea Hospital

Rockford, Illinois, 61103, United States

Location

Norton Healthcare

Louisville, Kentucky, 40241, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

University of Massachusetts

Worcester, Massachusetts, 01655, United States

Location

St. Louis University

St Louis, Missouri, 63110, United States

Location

University of Buffalo

Buffalo, New York, 14075, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Mercy Health St. Vincent Medical Center

Toledo, Ohio, 43604, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Geisinger Clinic

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Greenville Health System

Greenville, South Carolina, 61103, United States

Location

Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, 37403, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Texas Stroke Institute

Plano, Texas, 75075, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Algemeen Ziekenhuis Groeninge

Kortrijk, Belgium

Location

Centre Hospitalier Universitaire d'Amiens Picardie

Amiens, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, France

Location

Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille

Lille, France

Location

Praticien Hospitalier Université de Lorraine

Nancy, France

Location

Centre Hospitalier Regional Universitaire de Tours

Tours, France

Location

Universitatsklinikum Schleswig Holstein

Lübeck, Germany

Location

Galilee Hospital Naharyia

Nahariya, Israel

Location

Ospedale Niguarda Ca' Granda

Milan, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Ospedale Cannizzaro

Sicily, Italy

Location

Aichi Medical University Hospital

Aichi, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Japan

Location

Tominaga Hospital

Osaka, Japan

Location

Kohnan Hospital

Sendai, Japan

Location

Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital

Yokohama, Japan

Location

Centro Hospitalar de Vila Nova de Gaia

Porto, Portugal

Location

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Location

Hopitaux Universitaires de Geneve

Geneva, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Cerenovus Clinical Research Director
• Organization: CERENOVUS

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Reade De Leacy

  Mount Sinai Hospital, New York

  PRINCIPAL INVESTIGATOR

• Osama Zaidat

  Mercy Health St. Vincent Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 22, 2018
• Study Start: August 23, 2018
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-06

Locations

FR (5); ES (1); US (30); PT (1); CH (2); DE (1); IL (1); JP (6); BE (1); IT (3)