Trial document




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  DRKS00012438

Trial Description

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Title

Flow Diverter for Treatment of Ruptured Intracranial Aneurysms

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Subarachnoidal hemorrhages (SAH) due to dissecting or blood-blister like aneurysms are therapeutically very challenging. Earlier neurosurgical therapies failed to reliably protect patients from early rebleeds. Stent-assisted coiling has proven more effective as was demonstrated in recent studies. Yet coiling of these very delicate aneurysms carries the inherent risk of procedural aneurysm rupture with devastating consequences, since these patients are often loaded with Aspirin and Plavix. The use of flow diverters (FD) in this situation has been discussed and several cases have been reported in the recent past.
Aim of this retrospective multicenter study is to create a database including the greatest number of patients possible that
received FD treatment of ruptured aneurysms with FD.

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Organizational Data

  •   DRKS00012438
  •   2017/07/03
  •   [---]*
  •   yes
  •   Approved
  •   177/17, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   U1111-1196-5594 
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Health Condition or Problem studied

  •   I60.9 -  Subarachnoid haemorrhage, unspecified
  •   I67.10 -  [generalization I67.1: Cerebral aneurysm, nonruptured]
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Interventions/Observational Groups

  •   Data of patients, who suffered acute / subacute SAH and were treated with any kind of flow diverter between 01.1.2012 and 01.07.2017 will be assessed and analysed in regard to questions mentioned under primary / secondary endpoints.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Clinical outcome at 12 months (+- 6 months) follow up (mRS)

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Secondary Outcome

Type of aneurysm treated (dissecting, blood blister-like, saccular), delay between aneurysm rupture and treatment (early treatment vs. treatment in subacute phase), protocol for double antiplatelet therapy, additional coiling, rate of early rebleed, any rebleed during follow-up, angiographic outcome at 12 months

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Countries of Recruitment

  •   Germany
  •   Netherlands
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/01
  •   70
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Any patient treated for ruptured intracranial aneurysms with any kind of FD between 01.01.2012 and 01.07.2017.

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Exclusion Criteria

Important data missing

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für NeuroradiologieUNIVERSITAETSKLINIKUM FREIBURG
    • Mr.  Professor Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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    • Klinik für NeuroradiologieUNIVERSITAETSKLINIKUM FREIBURG
    • Mr.  Professor Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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    • Klinik für NeuroradiologieUNIVERSITAETSKLINIKUM FREIBURG
    • Mr.  Professor Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für NeuroradiologieUNIVERSITAETSKLINIKUM FREIBURG
    • Mr.  Professor Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
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* This entry means the parameter is not applicable or has not been set.