Trial document




This trial has been registered retrospectively.
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  DRKS00004695

Trial Description

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Title

Histopathological Analysis of Thrombi Retrieved with Stent Retrievers in Acute Ischemic Stroke Treatment: Evidence of Endothelial Damage?

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Trial Acronym

HATS

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URL of the Trial

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Brief Summary in Lay Language

In the present study we include patients that present with acute occlusion of brain arteries, a so called stroke. Treatment for acute stroke consists, among others of the mechanical removal of the thrombus from the occluded vessel. To exclude any damage to the inner vessel wall, related to the mechanical removal of the thrombus we test the thrombi retrieved for the presence of any bits and pieces of the inner vessel wall. This study allows us to better understand the potential risks that might be associated to mechanical removal of thrombi from occluded brain vessels.

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Brief Summary in Scientific Language

Thrombolysis with intravenous administration of recombinant tissue plasminogen activator (rt-PA) has proven effective in randomised controlled trials. However, in large vessel occlusion with high thrombus burden poor recanalization rates with limited patient outcome have been reported. Most recently a new class of mechanical thrombectomy devices has been brought to clinical practice with promising results and reported recanalization rates ranging from 67% to 100%. However, the stress to the vessel wall related to stent-retrieval seems important. During retraction of the stent-retriever the vascular anatomy may be distorted and considerable vasospasm of the target vessel and along the course of the stent-retriever are observed on a regular basis. So far no histopathological data on the effect of mechanical thrombectomy with stent-retrievers on the initima in men is available.
In this study we analyzed whether withdrawal of the unfolded stent by mechanical force to perform thrombectomy in acute ischemic stroke causes intimal injury. We therefore analyse thrombi retrieved from acutely occluded vessels with stent-retrievers,for occurrence of denuded endothelial cells with immunohistochemistry (CD34).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004695
  •   2013/01/30
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  •   yes
  •   Approved
  •   440/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   I63.0 -  Cerebral infarction due to thrombosis of precerebral arteries
  •   I63.3 -  Cerebral infarction due to thrombosis of cerebral arteries
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Interventions/Observational Groups

  •   Immunohistochemical analysis of thrombi obtained during mechanical thrombectomy with stent-retriever for the treatment of acute ischemic stroke.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Immunohistochemical detection of endothelial cells in thrombi

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Secondary Outcome

Neurorlogical status upon presentation (NIHSS), stroke etiology (TOAST), time-of-onset, time of treatment, recanalisation result (TICI score), Vasospasm related to treatment, Neurological status upon discharge (NIHSS)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/11/15
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients where thrombus-material was collected during mechanical thrombectomy with stent-retriever

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Exclusion Criteria

Age <18 years, Use of stentretriever outside treatment of acute ischamic stroke

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Addresses

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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  PD Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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    • Neuropathologie, Universitätsklinikum Freiburg
    • Mr.  Dr.  Soroush  Doostkam 
    • Breisacherstrasse 64
    • 79106  Freiburg
    • Germany
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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  PD Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  PD Dr.  Christian  Taschner 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Neuroradiologie Neurozentrum Universitätsklinikum Freiburg
    • Mr.  Prof.  Martin  Schumacher 
    • Breisacher Strasse 64
    • 79102  FREIBURG
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/01/11
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Trial Publications, Results and other Documents

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