En studie for å se på ytelsen til MICRUSFRAME og GALAXY spoler for behandling av intrakranielle aneurismer (STERLING)
12. juni 2026 oppdatert av: Cerenovus, Part of DePuy Synthes Products, Inc.
En prospektiv, multi-senter, enkeltarmsstudie for å skaffe kliniske data fra den virkelige verden og karakterisere den akutte og langsiktige ytelsen til MICRUSFRAME- og GALAXY-spolene, inkludert PulseRider-aneurisme-halsrekonstruksjonsenheten for endovaskulær behandling av intrakranielle aneurismer
Et post-markedsregister som evaluerer rupturerte/usprukkede aneurismer behandlet med MICRUSFRAME og GALAXY coils
Studieoversikt
Detaljert beskrivelse
Et register for å samle inn virkelige data om bruken av Cerenovus-spoler.
Studien vil være et post-markedsregister som evaluerer rupturerte/ubruttede aneurismer behandlet med MICRUSFRAME og GALAXY coils
Studietype
Intervensjonell
Registrering (Faktiske)
723
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Kortrijk, Belgia
- Algemeen Ziekenhuis Groeninge
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Arizona
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Tucson, Arizona, Forente stater, 85724
- University of Arizona
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California
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Carmichael, California, Forente stater, 95608
- Mercy San Juan Medical Center
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Orange, California, Forente stater, 92868
- University of California Irvine
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Florida
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Gainesville, Florida, Forente stater, 32608
- University of Florida
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Jacksonville, Florida, Forente stater, 32207
- Baptist Medical Center
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Miami, Florida, Forente stater, 33136
- University of Miami
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Georgia
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Savannah, Georgia, Forente stater, 31405
- Memorial Health University
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Illinois
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Chicago, Illinois, Forente stater, 60612
- University of Illinois
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Chicago, Illinois, Forente stater, 60612
- Rush University
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Rockford, Illinois, Forente stater, 61103
- Javon Bea Hospital
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Kentucky
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Louisville, Kentucky, Forente stater, 40241
- Norton Healthcare
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Maine
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Scarborough, Maine, Forente stater, 04074
- Maine Medical Center
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01655
- University of Massachusetts
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Missouri
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St Louis, Missouri, Forente stater, 63110
- St. Louis University
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New York
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Buffalo, New York, Forente stater, 14075
- University of Buffalo
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New York, New York, Forente stater, 10029
- Mount Sinai Hospital
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Stony Brook, New York, Forente stater, 11794
- Stony Brook University
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Valhalla, New York, Forente stater, 10595
- Westchester Medical Center
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
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Ohio
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Toledo, Ohio, Forente stater, 43604
- Mercy Health St. Vincent Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- University of Oklahoma Health Sciences Center
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Oregon
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Portland, Oregon, Forente stater, 97239
- Oregon Health and Science University
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Geisinger Clinic
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Medical University of South Carolina
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Greenville, South Carolina, Forente stater, 61103
- Greenville Health System
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37403
- Tennessee Interventional and Imaging Associates
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Knoxville, Tennessee, Forente stater, 37920
- University Of Tennessee
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Texas
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Plano, Texas, Forente stater, 75075
- Texas Stroke Institute
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- University of Utah
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia
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Amiens, Frankrike
- Centre Hospitalier Universitaire d'Amiens Picardie
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Bordeaux, Frankrike
- Centre Hospitalier Universitaire de Bordeaux
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Lille, Frankrike
- Hopital Roger Salengro-Centre Hospitalier Universitaire de Lille
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Nancy, Frankrike
- Praticien Hospitalier Université de Lorraine
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Tours, Frankrike
- Centre Hospitalier Régional Universitaire de Tours
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Nahariya, Israel
- Galilee Hospital Naharyia
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Milan, Italia
- Ospedale Niguarda Ca' Granda
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Roma, Italia
- Policlinico Tor Vergata
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Sicily, Italia
- 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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Valencia, Spania
- Hospital Universitari i Politecnic La Fe
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Geneva, Sveits
- Hôpitaux universitaires de Genève
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Zurich, Sveits
- University Hospital Zurich
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Lübeck, Tyskland
- Universitatsklinikum Schleswig Holstein
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
21 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Pasienten er mellom 21 og 80 år
- Pasienten har en intrakraniell sakkulær aneurisme, sprukket eller usprukket, egnet for embolisering med spiral
- Pasienten er i stand til og villig til å overholde protokoll- og oppfølgingskrav
Ekskluderingskriterier:
- Forhåndsplanlagt trinnvis prosedyre på ubrutt aneurisme
- Mer enn én aneurisme som krever behandling i løpet av studiet
- Fusiform aneurisme
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Spoler
MICRUSFRAME og GALAXY spoler
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MICRUSFRAME og GALAXY Coils
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Reade De Leacy, Mount Sinai Hospital, New York
- Hovedetterforsker: Osama Zaidat, Mercy Health St. Vincent Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
23. august 2018
Primær fullføring (Faktiske)
12. juni 2025
Studiet fullført (Faktiske)
12. juni 2025
Datoer for studieregistrering
Først innsendt
11. juli 2018
Først innsendt som oppfylte QC-kriteriene
21. august 2018
Først lagt ut (Faktiske)
22. august 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CNV_2017_01
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Ja
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