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Acute Ischemic StrokeGSR-ETNCT03356392

German Stroke Registry - Endovascular Treatment

An observational study of Acute Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
telephone call d90
How many people
10,000 participants
Where
1 siteGermany
Study dates
Jun 2015to Jun 2027
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maximilian Schell contact

+49 (0)1522/2834807

m.schell@uke.de

Götz Thomalla, Prof. Dr. med. contact

+49 (0)40/7410-0

thomalla@uke.de

Germany1 site, 1 recruiting
  • University Medical Center Hamburg-Eppendorf (UKE)

    Hamburg, Free and Hanseatic City of Hamburg, 20251

    Maximilian Schell, +49 (0)1522/2834807, m.schell@uke.de

    Götz Thomalla, Prof. Dr. med., +49 (0)40/7410-0, thomalla@uke.de

    Recruiting

Other trials in Germany

About this study

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.

Being tested
telephone call d90
Keywords
acute stroke, thrombectomy, endovascular treatment
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telephone call d90Other

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

Study groups in NCT03356392
Study groupRoleWhat they receive
stroke patientsacute stroke patients treated with endovascular treatment combined with or without
Receives: Other: telephone call d90

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified Ranking Scale (mRS) on day 90

    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.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2017
  2. Study startJun 2015
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03356392
Sponsor's protocol ID
GSR-ET
Acronym
GSR-ET
Status last verified
Dec 2024
First submitted
22 Nov 2017
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Deb-Chatterji M, Pinho J, Flottmann F, Meyer L, Broocks G, Brekenfeld C, Reich A, Fiehler J, Gerloff C, Thomalla G; GSR-ET Investigators. Health-related quality of life after thrombectomy in young-onset versus older stroke patients: a multicenter analysis. J Neurointerv Surg. 2022 Nov;14(11):1145-1150. doi: 10.1136/neurintsurg-2021-017991. Epub 2021 Dec 7.

    PubMed 34876497
  • Kniep H, Bechstein M, Broocks G, Brekenfeld C, Flottmann F, van Horn N, Geest V, Faizy TD, Deb-Chatterji M, Alegiani A, Thomalla G, Gellissen S, Fiehler J, Hanning U, Meyer L; German Stroke Registry-Endovascular Treatment (GSR-ET). Early surrogates of outcome after thrombectomy in posterior circulation stroke. Eur J Neurol. 2022 Nov;29(11):3296-3306. doi: 10.1111/ene.15519. Epub 2022 Aug 28.

    PubMed 35933692
  • Wischmann J, Nolte CH, Riegler C, Siebert E, Boeckh-Behrens T, Wunderlich S, Berndt MT, Rattenberger A, Hafner F, Hoffmann V, Mohlenbruch MA, Purrucker J, Fischer TD, Kellert L; GSR-ET investigators. Nimodipine in catheter flush solutions is associated with reduced vasospasm risk in endovascular stroke treatment. J Neurointerv Surg. 2026 Sep 11:jnis-2026-025972. doi: 10.1136/jnis-2026-025972. Online ahead of print.

    PubMed 42728086
  • Ahmad B, Maier IL, Wasser K, Dakna M, Behme D, Schnieder M, Tsogkas I, Ernst M, Brehm A, Bahr M, Psychogios MN, Liman J; German Stroke Registry-Endovascular Treatment (GSR-ET). One-Stop Management Improves Outcome for Large Vessel Occlusion Stroke. Stroke Vasc Interv Neurol. 2025 Dec 18;6(1):e001941. doi: 10.1161/SVIN.125.001941. eCollection 2026 Jan.

    PubMed 41816517
  • Asperger H, Bode F, Ebrahimi T, Kindler C, Layer J, Meissner JN, Nitsch L, Shirvani O, Thielscher C, von Danwitz NM, Weller J, Dorn F, Petzold GC, Stosser S; GSR-ET Investigators. Impact of Severe Prestroke Disability on Outcomes After Mechanical Thrombectomy: A Multicenter Analysis. Stroke Vasc Interv Neurol. 2026 Jan 6;6(1):e002055. doi: 10.1161/SVIN.125.002055. eCollection 2026 Jan.

    PubMed 41816510
  • Hahn M, Groschel S, Lang LS, Othman AE, Groschel K, Uphaus T; German Stroke Registry - Endovascular Treatment (GSR-ET) investigators. Mortality within three months after nonfatal ischemic stroke treated by mechanical thrombectomy in routine care-data from the German Stroke Registry. Neurol Res Pract. 2025 Oct 1;7(1):71. doi: 10.1186/s42466-025-00427-7.

    PubMed 41035079
  • Tong X, Jia B, Ma G, Zhang X, Fiehler J, Flottmann F, Bechstein M, Broocks G, Hanning U, Kniep HC, Thomalla G, Deb-Chatterji M, Schon G, Zhang Y, Gao F, Ma N, Mo D, Miao Z, Meyer L; as the ANGEL-ACT & GSR-ET study group. Relationship Between Thrombolysis-to-Puncture Time and Outcomes of Endovascular Thrombectomy in Acute Ischemic Stroke. Neurol Clin Pract. 2025 Aug;15(4):e200434. doi: 10.1212/CPJ.0000000000200434. Epub 2025 Jul 11.

    PubMed 40656129
  • Heitkamp A, Hierholzer SM, Heitkamp C, Winkelmeier L, Meyer L, Bechstein M, Geest V, Broocks G, Brekenfeld C, Flottmann F, Schell M, Thomalla G, Faizy T, Fiehler J, Kniep HC, Gellissen S; German Stroke Registry -Endovascular Treatment (GSR-ET). Key to better outcomes in stroke intervention: early versus complete reperfusion in first pass recanalization. J Neurol. 2025 Jul 11;272(8):504. doi: 10.1007/s00415-025-13235-5.

    PubMed 40646337
  • Single C, Mengel A, Laichinger K, Sartor-Pfeiffer J, Selo N, Hennersdorf F, Bender B, Deb-Chatterji M, Thomalla G, Mbroh J, Poli S, Ziemann U, Ernemann U, Feil K; German Stroke Registry-Endovascular Treatment (GSR). Sex-Related Differences in Outcomes of Endovascular Treatment in Large Vessel Occlusion Stroke-Analyses From the German Stroke Registry-Endovascular Treatment. Eur J Neurol. 2025 Mar;32(3):e70092. doi: 10.1111/ene.70092.

    PubMed 40008680
  • Beckonert NM, Weller JM, Alegiani AC, Boeckh-Behrens T, Deb-Chatterji M, Hamann GF, Krause LU, Lehnen NC, Nitsch L, Poli S, Riedel C, Tiedt S, Zweynert S, Petzold GC, Dorn F, Bode FJ; GSR-ET investigators. Endovascular treatment of primary M3 occlusion stroke in clinical practice: analysis of the German Stroke Registry. Neurol Res Pract. 2024 Jul 18;6(1):36. doi: 10.1186/s42466-024-00330-7.

    PubMed 39020409
  • Heitkamp C, Heitkamp A, Winkelmeier L, Thaler C, Flottmann F, Schell M, Kniep HC, Broocks G, Heit JJ, Albers GW, Thomalla G, Fiehler J, Faizy TD. Predictors of futile recanalization in ischemic stroke patients with low baseline NIHSS. Int J Stroke. 2024 Dec;19(10):1102-1112. doi: 10.1177/17474930241264737. Epub 2024 Nov 19.

    PubMed 38888031
  • Winkelmeier L, Heitkamp C, Faizy TD, Broocks G, Kniep H, Meyer L, Bester M, Brekenfeld C, Schell M, Hanning U, Thomalla G, Fiehler J, Flottmann F. Prognostic value of recanalization attempts in endovascular therapy for M2 segment middle cerebral artery occlusions. Int J Stroke. 2024 Apr;19(4):422-430. doi: 10.1177/17474930231214769. Epub 2023 Nov 22.

    PubMed 37935652
  • Kniep H, Meyer L, Broocks G, Bechstein M, Guerreiro H, Winkelmeier L, Brekenfeld C, Flottmann F, Deb-Chatterji M, Alegiani A, Hanning U, Thomalla G, Fiehler J, Gellissen S; German Stroke Registry - Endovascular Treatment (GSR - ET). Predictors of functional outcome after thrombectomy for M2 occlusions: a large scale experience from clinical practice. Sci Rep. 2023 Oct 31;13(1):18740. doi: 10.1038/s41598-023-45232-x.

    PubMed 37907482
  • Winkelmeier L, Faizy TD, Brekenfeld C, Heitkamp C, Broocks G, Bechstein M, Steffen P, Schell M, Gellissen S, Kniep H, Thomalla G, Fiehler J, Flottmann F; German Stroke Registry - Endovascular Treatment (GSR). Comparison of Thrombolysis In Cerebral Infarction (TICI) 2b and TICI 3 reperfusion in endovascular therapy for large ischemic anterior circulation strokes. J Neurointerv Surg. 2024 Oct 14;16(11):1076-1082. doi: 10.1136/jnis-2023-020724.

    PubMed 37777256
  • Winkelmeier L, Faizy TD, Broocks G, Meyer L, Heitkamp C, Brekenfeld C, Thaler C, Steffen P, Schell M, Deb-Chatterji M, Hanning U, Kniep H, Maros ME, Thomalla G, Fiehler J, Flottmann FA; German Stroke Registry. Association Between Recanalization Attempts and Functional Outcome After Thrombectomy for Large Ischemic Stroke. Stroke. 2023 Sep;54(9):2304-2312. doi: 10.1161/STROKEAHA.123.042794. Epub 2023 Jul 26.

    PubMed 37492970

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Ischemic Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maximilian Schell (+49 (0)1522/2834807, m.schell@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Ranking Scale (mRS) on day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03356392, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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