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The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System (SUNRISE)

10. december 2018 opdateret af: Codman & Shurtleff

The SUNRISE Registry - A Multicenter Post-Market Surveillance With the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System

The objective of the registry is to evaluate the real world safety and performance of the CORDIS ENTERPRISE™ Vascular Reconstruction Device and Delivery System (VRD) to facilitate endovascular coil embolization of intracranial aneurysms.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

The data will be collected in consecutive subjects treated with the commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CORDIS ENTERPRISE™ VRD during the index procedure. While only limited inclusion or exclusion criteria are specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up up to 6 months. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the VRD placement, coiling procedure, application of antiplatelet medication and any other medical therapy to be provided according to local usual practice.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

105

Kontakter og lokationer

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

Studiesteder

      • Bruxelles, Belgien, 1070
        • Université Libre de Bruxelles

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients suffering of an intracranial aneurysm and necessitating an endovascular treatment.

Patients who meet all of the general inclusion criteria and none of the exclusion criteria and who agree to voluntarily sign a informed consent form will be enrolled into the study.

Beskrivelse

Inclusion Criteria:

  • The subject must be >= 18 years of age and less than 80 years.
  • Diagnosis of a ruptured (Hunt and Hess Grade I - III) or unruptured intracranial aneurysm at the time of the treatment
  • Subject (or his/her legal representative) provides written informed consent for the use of his/her peri-procedural and follow-up data

Exclusion Criteria:

  • Diagnosis of Hunt and Hess Grade IV or V subarachnoid hemorrhage at the time of the treatment
  • Severe co-morbidity associated with a life-expectancy of less than six months
  • Poor neurological status at baseline
  • Known allergies to Nitinol metal
  • Known allergies to aspirin, heparin, ticlopidine, or clopidogrel or unable or unwilling to tolerate therapy
  • Participation in an investigational drug or another device study is only allowed after written approval of the coordinating investigator or Cordis Medical Monitor.
  • Implantation of an intracranial stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
  • Implantation of carotid stent associated with the symptomatic distribution within 12 weeks prior to the index procedure
  • Atrial fibrillation or known cardiac disorders likely to be associated with cardioembolic symptoms.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
1 Endovascular
All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.
CORDIS ENTERPRISE™ VRD
Andre navne:
  • ENTERPRISE
  • Codman ENTERPRISE
  • Codman VRD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Successful Intracranial VRD Placement With Satisfactory Coil Mass Position Without the Occurrence of Any Device and/or Procedure Related Serious Adverse Event (SAE)
Tidsramme: Intra-procedure
Successful intracranial VRD placement is defined as stable VRD placement with complete coverage of the aneurysm neck and parent artery patency. Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
Intra-procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Device or Procedure Related Adverse Events (AEs)
Tidsramme: index procedure to discharge; an average of 3.8 days
Incidence of device or procedure related adverse events during the index procedure and till discharge
index procedure to discharge; an average of 3.8 days
Satisfactory Coil Mass Position
Tidsramme: 6 months
Satisfactory coil mass position is defined as VRD maintains coil position within the sac with parent artery patency as defined angiographically
6 months
Aneurysm Occlusion
Tidsramme: post procedure to 6 months
Aneurysm occlusion was assessed using the Raymond Scale (Class 1 - Complete Obliteration / Class 2 - Residual Neck / Class 3 - Residual Aneurysm)
post procedure to 6 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Bendszus Martin, MD, Wuerzburg University Hospital
  • Ledende efterforsker: Boris Lubicz, MD, Université Libre de Bruxelles

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. juni 2007

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2013

Datoer for studieregistrering

Først indsendt

13. juni 2007

Først indsendt, der opfyldte QC-kriterier

13. juni 2007

Først opslået (Skøn)

14. juni 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2018

Sidst verificeret

1. december 2018

Mere information

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 .

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