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Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

Primary Purpose

Ischemic Stroke, Acute Stroke

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Mechanical Thrombectomy

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring acute ischemic stroke, acute large vessel occlusion, thrombectomy, mild stroke;, prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Gang Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

modified Rankin Scale(mRS) score of 0 to 2

independent outcome at 90 days

Secondary Outcome Measures

modified Rankin Scale(mRS) score of 0 to 1

excellent outcome at 90 days

Full Information

NCT ID

NCT04526756

First Posted

August 22, 2020

Last Updated

August 25, 2020

Sponsor

Shanghai East Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04526756

Brief Title

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

Official Title

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms After Imaging Selection

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2016 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

June 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai East Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a prospective cohort study of patients with with mild ischemic stroke (NIHSS Score <6) and LVO. Patients were divided into 2 groups: MT or medical management.Baseline data and clinical outcomes were compared. A independent clinical outcome was defined as a modified Rankin Scale score of 0 to 2 at 90 days. A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Acute Stroke

Keywords

acute ischemic stroke, acute large vessel occlusion, thrombectomy, mild stroke;, prognosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

A prospective, non-randomized, controlled, outcome-blinded study

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Mechanical Thrombectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

modified Rankin Scale(mRS) score of 0 to 2

Description

independent outcome at 90 days

Time Frame

90 days

Secondary Outcome Measure Information:

Title

modified Rankin Scale(mRS) score of 0 to 1

Description

excellent outcome at 90 days

Time Frame

90 days

Other Pre-specified Outcome Measures:

Title

Symptomatic intracranial haemorrhage transformation

Description

Symptomatic intracranial haemorrhage (sICH) transformation was defined according to European Cooperative Acute Stroke Study (ECASS)-III criteria

Time Frame

36 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Li

Organizational Affiliation

Shanghai East Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gang Li

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200123

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30355094

Citation

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.

Results Reference

result

PubMed Identifier

28384632

Citation

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. Erratum In: Cerebrovasc Dis. ;43(5-6):313.

Results Reference

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PubMed Identifier

29724764

Citation

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.

Results Reference

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PubMed Identifier

29089458

Citation

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.

Results Reference

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PubMed Identifier

28768820

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

34777207

Citation

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.

Results Reference

derived

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Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

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