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

31. januar 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

980

Fase

  • Ikke anvendelig

Udvidet adgang

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Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Device
AMPLATZER PFO Occluder
Enhed: 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.
Andet: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott Medical Devices

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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)

1. august 2003

Primær færdiggørelse (Faktiske)

1. maj 2012

Studieafslutning (Faktiske)

1. maj 2016

Datoer for studieregistrering

Først indsendt

23. april 2007

Først indsendt, der opfyldte QC-kriterier

23. april 2007

Først opslået (Skøn)

24. april 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AGA-006
  • G990318

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 AMPLATZER PFO Occluder

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Finland

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner