En undersøgelse for at se på ydeevnen af MICRUSFRAME og GALAXY spoler til behandling af intrakranielle aneurismer (STERLING)
12. juni 2026 opdateret af: Cerenovus, Part of DePuy Synthes Products, Inc.
En prospektiv, multi-center, enkeltarmsundersøgelse for at opnå "den virkelige verden" kliniske data og karakterisere den akutte og langsigtede ydeevne af MICRUSFRAME og GALAXY spolerne inklusive PulseRider aneurisme halsrekonstruktionsanordning til endovaskulær behandling af intrakranielle aneurismer
Et post-market register, der evaluerer sprængte/ubrudte aneurismer behandlet med MICRUSFRAME og GALAXY spoler
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Et register til at indsamle data fra den virkelige verden om brugen af Cerenovus-spoler.
Undersøgelsen vil være et post-market register, der evaluerer bristede/ubrudte aneurismer behandlet med MICRUSFRAME og GALAXY coils
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
723
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kortrijk, Belgien
- Algemeen Ziekenhuis Groeninge
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona
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California
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Carmichael, California, Forenede Stater, 95608
- Mercy San Juan Medical Center
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Orange, California, Forenede Stater, 92868
- University of California Irvine
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Florida
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Gainesville, Florida, Forenede Stater, 32608
- University of Florida
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Medical Center
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Memorial Health University
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- University of Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rush University
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Rockford, Illinois, Forenede Stater, 61103
- Javon Bea Hospital
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Kentucky
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Louisville, Kentucky, Forenede Stater, 40241
- Norton Healthcare
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Maine
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Scarborough, Maine, Forenede Stater, 04074
- Maine Medical Center
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Massachusetts
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Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- St. Louis University
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New York
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Buffalo, New York, Forenede Stater, 14075
- University of Buffalo
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New York, New York, Forenede Stater, 10029
- Mount Sinai Hospital
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Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University
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Valhalla, New York, Forenede Stater, 10595
- Westchester Medical Center
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Ohio
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Toledo, Ohio, Forenede Stater, 43604
- Mercy Health St. Vincent Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Clinic
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
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Greenville, South Carolina, Forenede Stater, 61103
- Greenville Health System
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Tennessee
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Chattanooga, Tennessee, Forenede Stater, 37403
- Tennessee Interventional and Imaging Associates
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Knoxville, Tennessee, Forenede Stater, 37920
- University Of Tennessee
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Texas
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Plano, Texas, Forenede Stater, 75075
- Texas Stroke Institute
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Utah
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Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia
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Amiens, Frankrig
- Centre Hospitalier Universitaire d'Amiens Picardie
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Bordeaux, Frankrig
- Centre Hospitalier Universitaire de Bordeaux
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Lille, Frankrig
- Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille
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Nancy, Frankrig
- Praticien Hospitalier Université de Lorraine
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Tours, Frankrig
- Centre Hospitalier Régional Universitaire de Tours
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Nahariya, Israel
- Galilee Hospital Naharyia
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Milan, Italien
- Ospedale Niguarda Ca' Granda
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Roma, Italien
- Policlinico Tor Vergata
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Sicily, Italien
- Ospedale Cannizzaro
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Aichi, Japan
- Aichi Medical University Hospital
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Okayama, Japan
- Okayama University Hospital
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Osaka, Japan
- National Hospital Organization Osaka National Hospital
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Osaka, Japan
- Tominaga Hospital
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Sendai, Japan
- Kohnan Hospital
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Yokohama, Japan
- Meihokai Yokohama Shin-Toshi Brain Orthopedic Hospital
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Porto, Portugal
- Centro Hospitalar de Vila Nova de Gaia
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Geneva, Schweiz
- Hôpitaux universitaires de Genève
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Zurich, Schweiz
- University Hospital Zurich
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Valencia, Spanien
- Hospital Universitari i Politecnic La Fe
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Lübeck, Tyskland
- Universitatsklinikum Schleswig Holstein
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Patienten er mellem 21 og 80 år
- Patienten har en intrakraniel sakulær aneurisme, sprængt eller ubrudt, egnet til embolisering med spiraler
- Patienten er i stand til og villig til at overholde protokol- og opfølgningskrav
Ekskluderingskriterier:
- Forud planlagt trinvis procedure på ubrudt aneurisme
- Mere end én aneurisme, der kræver behandling i løbet af studiet
- Fusiform aneurisme
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Andet: Spoler
MICRUSFRAME og GALAXY spoler
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MICRUSFRAME og GALAXY Coils
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: At 1 year Post Procedure on Day 1
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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.
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At 1 year Post Procedure on Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Packing Density Percentage (%) as Assessed by Independent Core Lab
Tidsramme: During procedure (Day 1)
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Packing density was defined as the ratio of the volume of coils to the volume of the coiled part of the aneurysm achieved during the procedure.
Packing density is expressed as percentage.
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During procedure (Day 1)
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Number of Participants With Complete Occlusion at 1 Year as Assessed by the Independent Core Lab (Modified Raymond-Roy I Classification)
Tidsramme: At 1 year Post Procedure on Day 1
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Number of participants with complete occlusion at 1 year was reported as assessed by the independent core lab was reported.
Complete occlusion was defined as achieving Modified Raymond-Roy I classification at 1 year, as assessed by the independent core lab.
Modified Raymond-Roy I or II 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.
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At 1 year Post Procedure on Day 1
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Recanalization Rate at 1 Year as Assessed by Independent Core Lab
Tidsramme: At 1 year Post Procedure on Day 1
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Recanalization rate is defined as number of participants with recanalization.
Recanalization was defined as a worsening in aneurysm occlusion grading using the Modified Raymond-Roy Classification (MRRC) scale.
MRRC 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.
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At 1 year Post Procedure on Day 1
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Number of Participants With Modified Rankin Score (mRS) 0-2 With Unruptured Aneurysms
Tidsramme: From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
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Number of participants with mRS 0-2 with unruptured aneurysm was reported.
The Modified Rankin Scale (mRS) is a 7 point measure of functional outcome ranging from 0 to 6, where higher scores indicate greater disability.
A score of 0 reflects no symptoms, 1 denotes no significant disability despite minor symptoms, 2 indicates slight disability with independence in personal affairs, 3 corresponds to moderate disability requiring some help but able to walk unassisted, 4 represents moderately severe disability with dependence for bodily needs and inability to walk alone, 5 signifies severe disability requiring constant care, and 6 indicates death.
Increasing scores indicate worsening outcomes.
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From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
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Number of Participants With Retreatment (Surgical or Endovascular)
Tidsramme: From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
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Number of participants with any retreatment (surgical or endovascular) was reported.
Retreatment is defined as any type of additional treatment (surgical or endovascular) of the target aneurysm after the index procedure.
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From baseline (Day 1 of procedure) to 1 year post procedure on Day 1
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Number of Participants With Device Related Serious Adverse Events (SAEs)
Tidsramme: From Day of procedure (Day 1) up to 1 year
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An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated.
A serious adverse event (SAE) is defined as an adverse event that led to death, led to serious deterioration in the health of the participant, users, other persons as defined by one or more of the following: a life-threatening illness or injury, or a permanent impairment of a body structure or a body function including chronic diseases, or in-patient or prolonged hospitalization, or medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function led to fetal distress, fetal death or a congenital abnormality or birth defect including physical or mental impairment.
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From Day of procedure (Day 1) up to 1 year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Reade De Leacy, Mount Sinai Hospital, New York
- Ledende efterforsker: Osama Zaidat, Mercy Health St. Vincent Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
23. august 2018
Primær færdiggørelse (Faktiske)
12. juni 2025
Studieafslutning (Faktiske)
12. juni 2025
Datoer for studieregistrering
Først indsendt
11. juli 2018
Først indsendt, der opfyldte QC-kriterier
21. august 2018
Først opslået (Faktiske)
22. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CNV_2017_01
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ja
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Aneurismer
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Jeil Pharmaceutical Co., Ltd.Afsluttet