NCT04526756

Brief Summary

Mechanical thrombectomy(MT) has been recommended in patients with acute large vessel occlusion stroke(LVO) , especially for those with National Institutes of Health Stroke Scale (NIHSS) score ≥6. However, it is still unclear if patients with minor strokes and LVO also benefit from MT.The aim of this study was to evaluate the safety and efficacy of MT for acute LVO and mild symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

July 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

3.7 years

First QC Date

August 22, 2020

Last Update Submit

August 25, 2020

Conditions

Ischemic StrokeAcute Stroke

Keywords

acute ischemic strokeacute large vessel occlusionthrombectomymild stroke;prognosis

Outcome Measures

Primary Outcomes (1)

  • modified Rankin Scale(mRS) score of 0 to 2

    independent outcome at 90 days

    90 days

Secondary Outcomes (1)

  • modified Rankin Scale(mRS) score of 0 to 1

    90 days

Other Outcomes (1)

  • Symptomatic intracranial haemorrhage transformation

    36 hours

Study Arms (2)

Intervention group

EXPERIMENTAL

patients in this group will receive mechanical thrombectomy and standardized drug treatment of acute ischemic stroke

Procedure: Mechanical Thrombectomy

control group

NO INTERVENTION

patients in this group will receive standardized drug treatment of acute ischemic stroke

Interventions

Mechanical ThrombectomyPROCEDURE

Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment

Intervention group

Eligibility Criteria

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

You may qualify if:

  • acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs;
  • age≥18 years old;
  • the NIHSS score before evaluation of thrombectomy\<6;
  • large artery occlusion including Middle cerebral artery M1, proximal M2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio\>1.8 or basilar artery and posterior cerebral artery P1 occlusion

You may not qualify if:

  • Patients without prior functional independence (mRS score of \>2)
  • Patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography
  • patients in control group with neurological worsening and received rescue thrombectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gang Li

Shanghai, Shanghai Municipality, 200123, China

Location

Related Publications (7)

  • Sarraj A, Hassan A, Savitz SI, Grotta JC, Cai C, Parsha KN, Farrell CM, Imam B, Sitton CW, Reddy ST, Kamal H, Goyal N, Elijovich L, Reishus K, Krishnan R, Sangha N, Wu A, Costa R, Malik R, Mir O, Hasan R, Snodgrass LM, Requena M, Graybeal D, Abraham M, Chen M, McCullough LD, Ribo M. Endovascular Thrombectomy for Mild Strokes: How Low Should We Go? Stroke. 2018 Oct;49(10):2398-2405. doi: 10.1161/STROKEAHA.118.022114.

    PMID: 30355094RESULT

  • Dargazanli C, Consoli A, Gory B, Blanc R, Labreuche J, Preda C, Bourdain F, Decroix JP, Redjem H, Ciccio G, Mazighi M, Smajda S, Desilles JP, Riva R, Labeyrie PE, Coskun O, Rodesch G, Turjman F, Piotin M, Lapergue B; ETIS investigators. Is Reperfusion Useful in Ischaemic Stroke Patients Presenting with a Low National Institutes of Health Stroke Scale and a Proximal Large Vessel Occlusion of the Anterior Circulation? Cerebrovasc Dis. 2017;43(5-6):305-312. doi: 10.1159/000468995. Epub 2017 Apr 7.

    PMID: 28384632RESULT

  • Shang X, Lin M, Zhang S, Li S, Guo Y, Wang W, Zhang M, Wan Y, Zhou Z, Zi W, Liu X. Clinical Outcomes of Endovascular Treatment within 24 Hours in Patients with Mild Ischemic Stroke and Perfusion Imaging Selection. AJNR Am J Neuroradiol. 2018 Jun;39(6):1083-1087. doi: 10.3174/ajnr.A5644. Epub 2018 May 3.

    PMID: 29724764RESULT

  • Dargazanli C, Arquizan C, Gory B, Consoli A, Labreuche J, Redjem H, Eker O, Decroix JP, Corlobe A, Mourand I, Gaillard N, Ayrignac X, Charif M, Duhamel A, Labeyrie PE, Riquelme C, Ciccio G, Smajda S, Desilles JP, Gascou G, Lefevre PH, Mantilla-Garcia D, Cagnazzo F, Coskun O, Mazighi M, Riva R, Bourdain F, Labauge P, Rodesch G, Obadia M, Bonafe A, Turjman F, Costalat V, Piotin M, Blanc R, Lapergue B; ETIS REGISTRY Investigators. Mechanical Thrombectomy for Minor and Mild Stroke Patients Harboring Large Vessel Occlusion in the Anterior Circulation: A Multicenter Cohort Study. Stroke. 2017 Dec;48(12):3274-3281. doi: 10.1161/STROKEAHA.117.018113. Epub 2017 Oct 31.

    PMID: 29089458RESULT

  • Haussen DC, Lima FO, Bouslama M, Grossberg JA, Silva GS, Lev MH, Furie K, Koroshetz W, Frankel MR, Nogueira RG. Thrombectomy versus medical management for large vessel occlusion strokes with minimal symptoms: an analysis from STOPStroke and GESTOR cohorts. J Neurointerv Surg. 2018 Apr;10(4):325-329. doi: 10.1136/neurintsurg-2017-013243. Epub 2017 Aug 2.

    PMID: 28768820RESULT

  • Kaesmacher J, Chaloulos-Iakovidis P, Panos L, Mordasini P, Heldner MR, Kurmann CC, Michel P, Hajdu SD, Ribo M, Requena M, Maegerlein C, Friedrich B, Costalat V, Benali A, Pierot L, Gawlitza M, Schaafsma J, Pereira VM, Gralla J, Fischer U. Clinical effect of successful reperfusion in patients presenting with NIHSS < 8: data from the BEYOND-SWIFT registry. J Neurol. 2019 Mar;266(3):598-608. doi: 10.1007/s00415-018-09172-1. Epub 2019 Jan 8.

    PMID: 30617997RESULT

  • Liu F, Shen H, Chen C, Bao H, Zuo L, Xu X, Yang Y, Cochrane A, Xiao Y, Li G. Mechanical Thrombectomy for Acute Stroke Due to Large-Vessel Occlusion Presenting With Mild Symptoms. Front Neurol. 2021 Oct 28;12:739267. doi: 10.3389/fneur.2021.739267. eCollection 2021.

    PMID: 34777207DERIVED

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gang Li

    Shanghai East Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, non-randomized, controlled, outcome-blinded study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2020

First Posted

August 26, 2020

Study Start

July 1, 2016

Primary Completion

March 15, 2020

Study Completion

June 20, 2020

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)