German Stroke Registry - Endovascular Treatment (GSR-ET)

December 5, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Maximilian Schell
  • Phone Number: +49 (0)1522/2834807
  • Email: m.schell@uke.de

Study Contact Backup

  • Name: Götz Thomalla, Prof. Dr. med.
  • Phone Number: +49 (0)40/7410-0
  • Email: thomalla@uke.de

Study Locations

  • Germany
      • Hamburg, Germany, 20251
        • Recruiting
        • University Medical Center Hamburg-Eppendorf (UKE)
        • Contact:
          • Maximilian Schell
          • Phone Number: +49 (0)1522/2834807
          • Email: m.schell@uke.de
        • Contact:
          • Götz Thomalla, Prof. Dr. med.
          • Phone Number: +49 (0)40/7410-0
          • Email: thomalla@uke.de
        • Contact:
          • Christian Gerloff, Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

Charite University, Berlin, Germany
Goethe University
University Hospital Muenster
RWTH Aachen University
Ludwig-Maximilians - University of Munich
University Hospital, Bonn
University Hospital Tuebingen
Wuerzburg University Hospital
University Hospital of Cologne
Sana Klinikum Offenbach
University of Göttingen
University Medical Center Rostock
University Medical Center Mainz
Klinikum Stadt Hanau
Klinikum Altenburger Land
Klinikum rechts der Isar, Technical University of Munich
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Klinikum Dortmund
KRH Klinikum Nordstadt
Asklepios Klinik Altona
Klinikum Lüneburg
Krankenhaus Buchholz
Klinikum Osnabrück
University of Giessen and Marburg
Sana Kliniken Lübeck
Mühlenkreiskliniken Minden
radprax MVZ Nordrhein
Asklepios Klinik Wandsbek
Elbe Kliniken
Städtische Klinikum Braunschweig
Allgemeines Krankenhaus Celle
Bezirkskrankenhaus Günzburg
Klinikum Bremen-Mitte, gGmbH
Klinikum Köln-Merheim

Investigators

  • Principal Investigator: Martin Dichgans, Prof. Dr. med., LMU, Munich, Germany
  • Principal Investigator: Christian Gerloff, Prof. Dr. med., UKE, Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSR-ET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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