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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

Study Description
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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.

Condition or disease Intervention/treatment
Acute Ischemic Stroke Other: telephone call d90

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: German Stroke Registry - Endovascular Treatment
Actual Study Start Date : June 2015
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
stroke patients
acute stroke patients treated with endovascular treatment combined with or without
 Other: telephone call d90
telephone call on day 90 to assess the primary outcome (mRs d90)


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356392


Contacts
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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

Locations
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Germany
University Medical Center Hamburg-Eppendorf (UKE) Recruiting
Hamburg, Germany, 20251
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   
Principal Investigator: Christian Gerloff, Prof. Dr. med.         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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
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Principal Investigator: Martin Dichgans, Prof. Dr. med. LMU, Munich, Germany
Principal Investigator: Christian Gerloff, Prof. Dr. med. UKE, Hamburg, Germany
More Information
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Additional Information:

Publications:
Alegiani AC, Dorn F, Herzberg M, Wollenweber FA, Kellert L, Siebert E, Nolte CH, von Rennenberg R, Hattingen E, Petzold GC, Bode FJ, Pfeilschifter W, Schafer JH, Wagner M, Rother J, Eckert B, Kraft P, Pham M, Boeckh-Behrens T, Wunderlich S, Bernkopf K, Reich A, Wiesmann M, Mpotsaris A, Psychogios M, Liman J, Maier I, Berrouschot J, Bormann A, Limmroth V, Spreer J, Petersen M, Krause L, Lowens S, Kraemer C, Zweynert S, Lange KS, Thonke S, Kastrup A, Papanagiotou P, Alber B, Braun M, Fiehler J, Gerloff C, Dichgans M, Thomalla G. Systematic evaluation of stroke thrombectomy in clinical practice: The German Stroke Registry Endovascular Treatment. Int J Stroke. 2019 Jun;14(4):372-380. doi: 10.1177/1747493018806199. Epub 2018 Oct 22. Erratum In: Int J Stroke. 2018 Dec 17;:1747493018816194. Eur J Prev Cardiol. 2020 Nov;27(17):NP16.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03356392    
Other Study ID Numbers: GSR-ET
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
acute stroke, thrombectomy, endovascular treatment
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases