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Clinical Trials/NCT03356392
NCT03356392RecruitingNot Applicable

German Stroke Registry - Endovascular Treatment

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country10,000 target enrollmentStarted: June 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10,000
Locations
1
Primary Endpoint
modified Ranking Scale (mRS) on day 90

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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