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Trial record 1 of 5 for:    GSR | stroke
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German Stroke Registry - Endovascular Treatment (GSR-ET)

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ClinicalTrials.gov Identifier: NCT03356392
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
Charite University, Berlin, Germany
University of Göttingen
University Hospital, Bonn
University Hospital, Frankfurt
Wuerzburg University Hospital
RWTH Aachen University
Technische Universität München
Asklepios Klinik Altona
Klinikum Osnabrück
Asklepios Klinik Wandsbek
Sana Klinikum Offenbach
Klinikum Dortmund
Krankenhaus Buchholz
Klinikum Lüneburg
KRH Klinikum Nordstadt
Kliniken Köln
Bezirkskliniken Schwaben Bezirkskrankenhaus Günzburg
Klinikum Altenburger Land
University Hospital Tuebingen
Klinikum Stadt Hanau
Universitätsklinikum Köln
Klinikum Bremen-Mitte, gGmbH
Uniklinikum Giessen und Marburg
University Hospital Muenster
Klinikum der Universitaet Muenchen
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date November 22, 2017
First Posted Date November 29, 2017
Last Update Posted Date January 30, 2018
Actual Study Start Date June 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2017)
modified ranking scale on day (mRs) day 90 [ Time Frame: 90 days ]
mRs: modified ranking scale; the scale is a commonly used measurement for the degree of disability or dependence in the daily activities of people who have suffered a stroke; scale range 0-6, with 0 - No symptoms. 1 - No significant disability. Able to carry out all usual activities, despite some symptoms. 2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3 - Moderate disability. Requires some help, but able to walk unassisted. 4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Dead. publication: van Swieten J, Koudstaal P, Visser M, Schouten H, et al. (1988). "Interobserver agreement for the assessment of handicap in stroke patients". Stroke. 19 (5): 604-607. doi:10.1161/01.str.19.5.604. PMID 3363593.
Original Primary Outcome Measures
 (submitted: November 22, 2017)
modified ranking scale on day (mRs) day 90 [ Time Frame: 90 days ]
modified ranking scale on day 90
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title German Stroke Registry - Endovascular Treatment
Official Title German Stroke Registry - Endovascular Treatment
Brief Summary The German Stroke Registry (GSR) Endovascular Treatment is an academic, independent, prospective, multicentre, observational registry study. Consecutive patients treated with endovascular stroke treatment will be enrolled in German stroke centers. Patients receive regular care and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of interventional treatment, procedural complications, intracranial hemorrhage, and functional outcome.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 90 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population all acute stroke patients with the clinical diagnosis of acute ischemic stroke, eligible for IVT and IVT initiated within 4.5 hours after stroke onset, Age >18 years
Condition Acute Ischemic Stroke
Intervention Other: telephone call d90
telephone call on day 90 to assess the primary outcome (mRs d90)
Study Groups/Cohorts stroke patients
acute stroke patients treated with endovascular treatment combined with thrombolysis or without previous thrombolysis Intervention: telephone call on day 90 to assess the primary outcome (mRs d90)
Intervention: Other: telephone call d90
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 22, 2017)
2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of acute ischemic stroke
  • Eligible for intravenous thrombolysis (IVT) and IVT initiated within 4.5 hours after stroke onset
  • Confirmed diagnosis of persistent occlusion of terminal carotid artery, middle cerebral artery (M1 or M2), or basilar artery consistent with symptoms
  • Age >18 years
  • Ethic approval in process

Exclusion Criteria:

none

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Anna Christina Alegiani, Dr 0049-15222816679 a.alegiani@uke.de
Contact: Frank Wollenweber, PD Dr. +49 (0)89 4400 - 46046 frank.wollenweber@med.uni-muenchen.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03356392
Other Study ID Numbers GSR-ET
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators
  • Charite University, Berlin, Germany
  • University of Göttingen
  • University Hospital, Bonn
  • University Hospital, Frankfurt
  • Wuerzburg University Hospital
  • RWTH Aachen University
  • Technische Universität München
  • Asklepios Klinik Altona
  • Klinikum Osnabrück
  • Asklepios Klinik Wandsbek
  • Sana Klinikum Offenbach
  • Klinikum Dortmund
  • Krankenhaus Buchholz
  • Klinikum Lüneburg
  • KRH Klinikum Nordstadt
  • Kliniken Köln
  • Bezirkskliniken Schwaben Bezirkskrankenhaus Günzburg
  • Klinikum Altenburger Land
  • University Hospital Tuebingen
  • Klinikum Stadt Hanau
  • Universitätsklinikum Köln
  • Klinikum Bremen-Mitte, gGmbH
  • Uniklinikum Giessen und Marburg
  • University Hospital Muenster
  • Klinikum der Universitaet Muenchen
Investigators
Principal Investigator: Martin Dichgans, Prof LMU, Munich, Germany
Principal Investigator: Christian Gerloff, Prof UKE, Hamburg, Germany
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date January 2018