NCT03356392

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2015Jun 2027

Study Start

First participant enrolled

June 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

12 years

First QC Date

November 22, 2017

Last Update Submit

December 5, 2024

Conditions

Keywords

acute stroke, thrombectomy, endovascular treatment

Outcome Measures

Primary Outcomes (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.

    90 days

Study Arms (1)

stroke patients

acute stroke patients treated with endovascular treatment combined with or without

Other: telephone call d90

Interventions

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

stroke patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf (UKE)

Hamburg, Hamburg, 20251, Germany

RECRUITING

Related Publications (25)

  • 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.

    PMID: 34876497BACKGROUND
  • 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.

    PMID: 35933692BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • Hahn M, Groschel S, Othman A, Brockstedt L, Civelek A, Brockmann MA, Groschel K, Uphaus T; German Stroke Registry Endovascular Treatment-Steering Committee. Real world data in mechanical thrombectomy: who are we losing to follow-up? J Neurointerv Surg. 2024 Apr 23;16(5):471-477. doi: 10.1136/jnis-2023-020435.

  • Weller JM, Dorn F, Meissner JN, Stosser S, Beckonert NM, Nordsiek J, Kindler C, Riegler C, Keil F, Petzold GC, Bode FJ; GSR-ET investigators. Antithrombotic treatment and outcome after endovascular treatment and acute carotid artery stenting in stroke patients with atrial fibrillation. Neurol Res Pract. 2022 Sep 12;4(1):42. doi: 10.1186/s42466-022-00207-7.

  • Weller JM, Dorn F, Meissner JN, Stosser S, Beckonert NM, Nordsiek J, Kindler C, Deb-Chatterji M, Petzold GC, Bode FJ; GSR-ET investigators. Endovascular thrombectomy in young patients with stroke. Int J Stroke. 2023 Apr;18(4):453-461. doi: 10.1177/17474930221119602. Epub 2022 Sep 7.

  • Kniep H, Meyer L, Bechstein M, Broocks G, Guerreiro H, van Horn N, Brekenfeld C, Flottmann F, Deb-Chatterji M, Alegiani A, Thomalla G, Hanning U, Fiehler J, Gellissen S; GSR-ET (German Stroke Registry-Endovascular Treatment). How Much of the Thrombectomy Related Improvement in Functional Outcome Is Already Apparent at 24 Hours and at Hospital Discharge? Stroke. 2022 Sep;53(9):2828-2837. doi: 10.1161/STROKEAHA.121.037888. Epub 2022 May 13.

  • Hahn M, Groschel S, Hayani E, Brockmann MA, Muthuraman M, Groschel K, Uphaus T; German Stroke Registry-Endovascular Treatment (GSR-ET) Study Group. Sex Disparities in Re-Employment in Stroke Patients With Large Vessel Occlusion Undergoing Mechanical Thrombectomy. Stroke. 2022 Aug;53(8):2528-2537. doi: 10.1161/STROKEAHA.121.037386. Epub 2022 Apr 21.

  • Meyer L, Bechstein M, Bester M, Hanning U, Brekenfeld C, Flottmann F, Kniep H, van Horn N, Deb-Chatterji M, Thomalla G, Sporns P, Yeo LL, Tan BY, Gopinathan A, Kastrup A, Politi M, Papanagiotou P, Kemmling A, Fiehler J, Broocks G; German Stroke Registry-Endovascular Treatment (GSR-ET). Thrombectomy in Extensive Stroke May Not Be Beneficial and Is Associated With Increased Risk for Hemorrhage. Stroke. 2021 Oct;52(10):3109-3117. doi: 10.1161/STROKEAHA.120.033101. Epub 2021 Sep 2.

  • Weller JM, Enkirch SJ, Bogs C, Braemswig TB, Deb-Chatterji M, Keil F, Kindler C, Maywald S, Schirmer MD, Stosser S, Solymosi L, Nolte CH, Bode FJ, Petzold GC; GSR-ET Investigators. Endovascular Treatment for Acute Stroke in Cerebral Amyloid Angiopathy. Stroke. 2021 Oct;52(10):e581-e585. doi: 10.1161/STROKEAHA.120.033014. Epub 2021 Aug 20.

  • Maros ME, Brekenfeld C, Broocks G, Leischner H, McDonough R, Deb-Chatterji M, Alegiani A, Thomalla G, Fiehler J, Flottmann F; GSR Investigators*. Number of Retrieval Attempts Rather Than Procedure Time Is Associated With Risk of Symptomatic Intracranial Hemorrhage. Stroke. 2021 May;52(5):1580-1588. doi: 10.1161/STROKEAHA.120.031242. Epub 2021 Apr 5.

  • Herm J, Schlemm L, Siebert E, Bohner G, Alegiani AC, Petzold GC, Pfeilschifter W, Tiedt S, Kellert L, Endres M, Nolte CH. How do treatment times impact on functional outcome in stroke patients undergoing thrombectomy in Germany? Results from the German Stroke Registry. Int J Stroke. 2021 Oct;16(8):953-961. doi: 10.1177/1747493020985260. Epub 2021 Jan 20.

  • Flottmann F, Brekenfeld C, Broocks G, Leischner H, McDonough R, Faizy TD, Deb-Chatterji M, Alegiani A, Thomalla G, Mpotsaris A, Nolte CH, Fiehler J, Maros ME; GSR investigators*. Good Clinical Outcome Decreases With Number of Retrieval Attempts in Stroke Thrombectomy: Beyond the First-Pass Effect. Stroke. 2021 Jan;52(2):482-490. doi: 10.1161/STROKEAHA.120.029830. Epub 2021 Jan 20.

  • Kupper C, Feil K, Wollenweber FA, Tiedt S, Herzberg M, Dorn F, Liebig T, Dieterich M, Kellert L; GSR investigators. Endovascular stroke treatment in orally anticoagulated patients: an analysis from the German Stroke Registry-Endovascular Treatment. J Neurol. 2021 May;268(5):1762-1769. doi: 10.1007/s00415-020-10369-6. Epub 2020 Dec 29.

  • Ettelt P, Maier IL, Schnieder M, Bahr M, Behme D, Psychogios MN, Liman J; GSR-ET Collaborators. Bridging therapy is associated with improved cognitive function after large vessel occlusion stroke - an analysis of the German Stroke Registry. Neurol Res Pract. 2020 Jul 27;2:29. doi: 10.1186/s42466-020-00079-9. eCollection 2020.

  • Wollenweber FA, Tiedt S, Alegiani A, Alber B, Bangard C, Berrouschot J, Bode FJ, Boeckh-Behrens T, Bohner G, Bormann A, Braun M, Dorn F, Eckert B, Flottmann F, Hamann GF, Henn KH, Herzberg M, Kastrup A, Kellert L, Kraemer C, Krause L, Lehm M, Liman J, Lowens S, Mpotsaris A, Papanagiotou P, Petersen M, Petzold GC, Pfeilschifter W, Psychogios MN, Reich A, von Rennenberg R, Rother J, Schafer JH, Siebert E, Siedow A, Solymosi L, Thonke S, Wagner M, Wunderlich S, Zweynert S, Nolte CH, Gerloff C, Thomalla G, Dichgans M, Fiehler J. Functional Outcome Following Stroke Thrombectomy in Clinical Practice. Stroke. 2019 Sep;50(9):2500-2506. doi: 10.1161/STROKEAHA.119.026005. Epub 2019 Jul 24.

  • 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.

Related Links

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Dichgans, Prof. Dr. med.

    LMU, Munich, Germany

    PRINCIPAL INVESTIGATOR
  • Christian Gerloff, Prof. Dr. med.

    UKE, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximilian Schell

CONTACT

Götz Thomalla, Prof. Dr. med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2017

First Posted

November 29, 2017

Study Start

June 1, 2015

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations