Trial document





This trial has been registered retrospectively.
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  DRKS00006881

Trial Description

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Title

Endovascular Treatment of Intracranial Aneurysms with Surpass Flow Diverter. A retrospective multicenter study with respect to clinical and angiographic outcome

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Trial Acronym

SUR-POST

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URL of the Trial

http://Nicht vorgesehen

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Brief Summary in Lay Language

Aneurysms of the brain are standardly treated by clipping or endovascular coiling. A new approach is the usage of so called Flow Diverters. These are a special kind of stents with tight mashes. They divert the blood-flow along the aneurysm reducing the intraaneurysmal flow. This leads to subsequent thombosis and shrinkage of the aneurysm afterwards. The use of flow diverters is currently restricted to large and complex-formed aneurysms. The aim of the study is to evaluate the efficacy of this new treatment option in aneurysms of the posterior circulation. This is done by continual documentation of the clinical state of the patients which have received that treatment.

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Brief Summary in Scientific Language

A great number of prospective studies were able to prove the clinical effectiveness of the endovascular treatment of intracranial aneurysms with coils. However the classic coil-embolization finds its limit when it comes to large aneurysms or aneurysms with a wide neck. Here methods like remodelling-balloons or stents gained acceptance. Another approach consists of the so called Flow Diverters (FD). FD are stents with a very high density which lead to aneurysm occlusion by reducing the flow into the aneurysm. The effectiveness of FD has been shown in a variety of register studies. The placement of FD in the posterior circulation is a matter of on-going debate. The major risk seems occlusion of perforating arteries deriving from the distal segments of the vertebral arteries, as well as the basilar artery, and the posterior cerebral arteries. The Surpass FD has CE markage for intracranial aneurysm treatment. The Surpass FD is a FD with a particularly mesh density, when compared to the other FD available on the market.
The aim of this retrospective multicentre study is to analyze the effectiveness of the Surpass Flow Diverter for the treatment of aneurysms located within the posterior circulation with a special focus on the clinical outcome.

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Organizational Data

  •   DRKS00006881
  •   2015/04/10
  •   [---]*
  •   yes
  •   Approved
  •   376/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   intracranial aneurysm, posterior circulation
  •   I67.1 -  Cerebral aneurysm, nonruptured
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Interventions/Observational Groups

  •   Any male or female patient between 16 and 79 years of age that received FD treatment with Surpass for aneurysmatic disease within the posterior circulation between 07/2010 and 03/2015.
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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

Mortality in patients with intracranial aneurysms of the posterior circulation after flow-diverter treatment with the Surpass flow diverter (after 12 months) and complete occlusion in angiographic follow up (after 12 months).

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Secondary Outcome

Technical success rate, complication rate of aneurysm treatment with the Surpass flow-diverter, new neurological deficits after 24 hours, modified Rankin Scale (mRS) at discharge and morbidity (mRS 3 till 5) at follow-up.

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Countries of Recruitment

  •   Germany
  •   Netherlands
  •   France
  •   Hungary
  •   United States
  •   Japan
  •   Argentina
  •   Denmark
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2014/10/15
  •   53
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   16   Years
  •   80   Years
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Additional Inclusion Criteria

Any patient that received FD treatment with Surpass for aneurysmatic disease within the posterior circulation.

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Exclusion Criteria

Patients < 16 years of age

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Addresses

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    • Universitätsklinikum Freiburg Abteilung der Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung der Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg Abteilung der Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg Abteilung der Neuroradiologie
    • Mr.  Prof. Dr.  Christian  Taschner 
    • Breisacher Straße 64
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/06/15
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Trial Publications, Results and other Documents

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