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German Stroke Registry - Endovascular Treatment (GSR-ET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03356392
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : December 29, 2022
Sponsor:
Collaborators:
University Hospital of Cologne
Klinikum rechts der Isar, Technical University of Munich
RWTH Aachen University
University Hospital Tuebingen
Charite University, Berlin, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Sana Klinikum Offenbach
Goethe University
Klinikum Dortmund
KRH Klinikum Nordstadt
Asklepios Klinik Altona
Klinikum Altenburger Land
University Hospital, Bonn
Klinikum Stadt Hanau
Klinikum Lüneburg
Ludwig-Maximilians - University of Munich
University of Göttingen
Krankenhaus Buchholz
Klinikum Osnabrück
Wuerzburg University Hospital
University of Giessen and Marburg
Sana Kliniken Lübeck
Mühlenkreiskliniken Minden
radprax MVZ Nordrhein
University Hospital Muenster
University Medical Center Rostock
Asklepios Klinik Wandsbek
Elbe Kliniken
Städtische Klinikum Braunschweig
Allgemeines Krankenhaus Celle
Bezirkskrankenhaus Günzburg
Klinikum Bremen-Mitte, gGmbH
University Medical Center Mainz
Klinikum Köln-Merheim
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 December 29, 2022
Actual Study Start Date June 2015
Estimated Primary Completion Date June 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 28, 2022)		 modified Ranking Scale (mRS) on day 90 [ Time Frame: 90 days ]
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 or without
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: December 28, 2022)		 10000
Original Estimated Enrollment
 (submitted: November 22, 2017)		 2500
Estimated Study Completion Date June 2025
Estimated Primary Completion Date June 2025   (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: Maximilian Schell +49 (0)1522/2834807 m.schell@uke.de
Contact: Götz Thomalla, Prof. Dr. med. +49 (0)40/7410-0 thomalla@uke.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
Current Responsible Party Universitätsklinikum Hamburg-Eppendorf
Original Responsible Party Same as current
Current Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Original Study Sponsor Same as current
Collaborators
  • University Hospital of Cologne
  • Klinikum rechts der Isar, Technical University of Munich
  • RWTH Aachen University
  • University Hospital Tuebingen
  • Charite University, Berlin, Germany
  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
  • Sana Klinikum Offenbach
  • Goethe University
  • Klinikum Dortmund
  • KRH Klinikum Nordstadt
  • Asklepios Klinik Altona
  • Klinikum Altenburger Land
  • University Hospital, Bonn
  • Klinikum Stadt Hanau
  • Klinikum Lüneburg
  • Ludwig-Maximilians - University of Munich
  • University of Göttingen
  • Krankenhaus Buchholz
  • Klinikum Osnabrück
  • Wuerzburg University Hospital
  • University of Giessen and Marburg
  • Sana Kliniken Lübeck
  • Mühlenkreiskliniken Minden
  • radprax MVZ Nordrhein
  • University Hospital Muenster
  • University Medical Center Rostock
  • Asklepios Klinik Wandsbek
  • Elbe Kliniken
  • Städtische Klinikum Braunschweig
  • Allgemeines Krankenhaus Celle
  • Bezirkskrankenhaus Günzburg
  • Klinikum Bremen-Mitte, gGmbH
  • University Medical Center Mainz
  • Klinikum Köln-Merheim
Investigators
Principal Investigator: Martin Dichgans, Prof. Dr. med. LMU, Munich, Germany
Principal Investigator: Christian Gerloff, Prof. Dr. med. UKE, Hamburg, Germany
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date November 2022