GSR-ET: German Stroke Registry - Endovascular Treatment

Sponsor

Universitätsklinikum Hamburg-Eppendorf (Other)

Overall Status

Recruiting

CT.gov ID

NCT03356392

Collaborator

Charite University, Berlin, Germany (Other), University of Göttingen (Other), University Hospital, Bonn (Other), University Hospital Frankfurt (Other), Wuerzburg University Hospital (Other), RWTH Aachen University (Other), Technische Universität München (Other), Asklepios Klinik Altona (Other), Klinikum Osnabrück (Other), Asklepios Klinik Wandsbek (Other), Sana Klinikum Offenbach (Other), Klinikum Dortmund (Other), Krankenhaus Buchholz (Other), Klinikum Lüneburg (Other), KRH Klinikum Nordstadt (Other), Kliniken Köln (Other), Bezirkskliniken Schwaben Bezirkskrankenhaus Günzburg (Other), Klinikum Altenburger Land (Other), University Hospital Tuebingen (Other), Klinikum Stadt Hanau (Other), Universitätsklinikum Köln (Other), Klinikum Bremen-Mitte, gGmbH (Other), Uniklinikum Giessen und Marburg (Other), University Hospital Muenster (Other), LMU Klinikum (Other)

2,500

Enrollment

Location

120

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Acute Ischemic Stroke	Other: telephone call d90

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

German Stroke Registry - Endovascular Treatment

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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)	Other: telephone call d90 telephone call on day 90 to assess the primary outcome (mRs d90)

Arm

Intervention/Treatment

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)

Other: telephone call d90

telephone call on day 90 to assess the primary outcome (mRs d90)

Outcome Measures

Primary Outcome Measures

modified ranking scale on day (mRs) day 90 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center Hamburg-Eppendorf (UKE)	Hamburg		Germany	20251

Investigators

Principal Investigator: Martin Dichgans, Prof, LMU, Munich, Germany
Principal Investigator: Christian Gerloff, Prof, UKE, Hamburg, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Universitätsklinikum Hamburg-Eppendorf

ClinicalTrials.gov Identifier:

NCT03356392

Other Study ID Numbers:

GSR-ET

First Posted:

Nov 29, 2017

Last Update Posted:

Jan 30, 2018

Last Verified:

Jan 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Universitätsklinikum Hamburg-Eppendorf

acute stroke, thrombectomy, endovascular treatment

Additional relevant MeSH terms:

Stroke

Ischemic Stroke

Study Results

No Results Posted as of Jan 30, 2018