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Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

31. januar 2019 oppdatert av: Abbott Medical Devices

Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.

Studietype

Intervensjonell

Registrering (Faktiske)

980

Fase

  • Ikke aktuelt

Utvidet tilgang

Ikke lenger tilgjengelig utenfor den kliniske utprøvingen. Se utvidet tilgangspost.

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W5
        • Royal Columbian Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 1Y6
        • St. Paul's Hospital
    • Ontario
      • London, Ontario, Canada, N6G 2V2
        • Stroke Prevention & Atherosclerosis Research Center (SPARC) - Robarts Research Institute
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35249
        • University of Alabama
    • Arizona
      • Scottsdale, Arizona, Forente stater, 85259
        • Mayo Clinic
    • California
      • Los Angeles, California, Forente stater, 90095
        • UCLA
      • Los Angeles, California, Forente stater, 90033
        • LAC + USC Medical Center
      • Oakland, California, Forente stater, 94609
        • Summit Medical Center
      • San Diego, California, Forente stater, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, Forente stater, 94115
        • Kaiser Permanente
    • Colorado
      • Denver, Colorado, Forente stater, 80262
        • University of Colorado
      • Littleton, Colorado, Forente stater, 80120
        • South Denver Cardiology Associates
      • Loveland, Colorado, Forente stater, 80538
        • Medical Center of the Rockies
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20010
        • Washington Hospital Center
      • Washington, District of Columbia, Forente stater, 20037
        • George Washington University Hospital
    • Florida
      • Jacksonville, Florida, Forente stater, 32204
        • St. Vincent's Medical Center
    • Illinois
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago
      • Chicago, Illinois, Forente stater, 60611-3078
        • Northwestern University
      • Palos Heights, Illinois, Forente stater, 60463
        • Neurologic Associates Inc
      • Peoria, Illinois, Forente stater, 61637
        • OSF St. Francis Medical Center
      • Springfield, Illinois, Forente stater, 62702
        • Southern Illinois University Neurology
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46237
        • Indiana Heart Physicians
    • Iowa
      • Des Moines, Iowa, Forente stater, 50314
        • Ruan Neurology
      • Iowa City, Iowa, Forente stater, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
        • Kansas University Medical Center
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40536
        • University of Kentucky
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Towson, Maryland, Forente stater, 21014
        • Midatlantic Cardiovascular Associates
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02111
        • Tufts Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109-0316
        • University of Michigan Health System
    • Minnesota
      • Duluth, Minnesota, Forente stater, 55805
        • St. Mary's Duluth Clinic
      • Minneapolis, Minnesota, Forente stater, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Forente stater, 55407
        • Abbott Northwestern Hospital
      • Saint Louis Park, Minnesota, Forente stater, 55426
        • Methodist Hospital/Park Nicollet Medical Center
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198-2045
        • University of Nebraska Medical Center
    • New Jersey
      • Cherry Hill, New Jersey, Forente stater, 08034
        • Our Lady of Lourdes Medical Center
      • Newark, New Jersey, Forente stater, 07103
        • University of Medicine and Dentistry of New Jersy
    • New York
      • Albany, New York, Forente stater, 12208
        • Albany Medical Center
      • Amherst, New York, Forente stater, 14226
        • Dent Neurologic Institute
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • Greensboro, North Carolina, Forente stater, 27410
        • Moses H. Cone Memorial Hospital
    • Ohio
      • Akron, Ohio, Forente stater, 44320
        • Neurology and Neuroscience Associates
      • Cleveland, Ohio, Forente stater, 44106
        • University Hospitals of Cleveland
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, Forente stater, 97225
        • Providence St. Vincent's Medical Center
      • Portland, Oregon, Forente stater, 97329
        • Oregon Stroke Center, OHSU
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18105
        • Lehigh Valley Hospital
      • Hershey, Pennsylvania, Forente stater, 17033
        • Penn State Milton South Hershey Medical Center
      • Lancaster, Pennsylvania, Forente stater, 17543
        • Lancaster General Hospital
      • Langhorne, Pennsylvania, Forente stater, 19067
        • St. Mary's Medical Center
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls, South Dakota, Forente stater, 57108
        • North Central Heart Institute
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232-8802
        • Vanderbilt University
      • Nashville, Tennessee, Forente stater, 37205
        • St. Thomas Neurology
    • Texas
      • Dallas, Texas, Forente stater, 75390-8897
        • UT Southwestern Medical School
      • Houston, Texas, Forente stater, 77030
        • University of Texas Houston Health Science Center
    • Virginia
      • Virginia Beach, Virginia, Forente stater, 23454
        • Sentara Virginia Beach General Hospital
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • UW Medicine Stroke Center
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • Charleston Area Medical Center
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Hospital
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin

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

18 år til 60 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who have had a cryptogenic stroke within the last 270 days
  • Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
  • Subjects willing to participate in follow-up visits

Exclusion Criteria:

  • Subjects with intracardiac thrombus or tumor
  • Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
  • Subjects with left ventricular aneurysm or akinesis
  • Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
  • Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
  • Subjects with contraindication to aspirin or Clopidogrel therapy
  • Pregnant or desire to become pregnant within the next year

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Device
AMPLATZER PFO Occluder
Enhet: AMPLATZER PFO Occluder
patent foramen ovale closure device
Aktiv komparator: Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Annen: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Tidsramme: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.

Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct.

Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.

Sekundære resultatmål

Resultatmål
Tidsramme
Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group
Tidsramme: 6 months
6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Abbott Medical Devices

Etterforskere

  • Hovedetterforsker: Jeffrey Saver, MD, UCLA Stroke Center
  • Hovedetterforsker: John D Carroll, MD, University of Colorado, Denver
  • Hovedetterforsker: Richard Smalling, MD, University of Texas Houston Health Science Center
  • Hovedetterforsker: David Thaler, MD, Tufts Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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)

1. august 2003

Primær fullføring (Faktiske)

1. mai 2012

Studiet fullført (Faktiske)

1. mai 2016

Datoer for studieregistrering

Først innsendt

23. april 2007

Først innsendt som oppfylte QC-kriteriene

23. april 2007

Først lagt ut (Anslag)

24. april 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. februar 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. januar 2019

Sist bekreftet

1. januar 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AGA-006
  • G990318

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på AMPLATZER PFO Occluder

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Togo

Forhold

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Legemiddelintervensjoner

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