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Ischemic StrokeNCT04526756

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

A study testing Mechanical Thrombectomy in people with Ischemic Stroke and Acute Stroke, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke, Acute Stroke
What is being tested?
Mechanical Thrombectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteChina
Study dates
1 Jul 2016to 20 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Gang Li

    Shanghai, Shanghai Municipality, 200123

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Mechanical Thrombectomy
Keywords
acute ischemic stroke, acute large vessel occlusion, thrombectomy, mild stroke;, prognosis
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.

  • Mechanical ThrombectomyProcedure or surgery

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

Study groups in NCT04526756
Study groupRoleWhat they receive
Intervention groupExperimentalpatients in this group will receive mechanical thrombectomy and standardized drug treatment of acute ischemic stroke
Receives: Procedure: Mechanical Thrombectomy
control groupNo interventionpatients in this group will receive standardized drug treatment of acute ischemic stroke

What is being measured

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

  1. modified Rankin Scale(mRS) score of 0 to 2

    independent outcome at 90 days

    Measured: 90 days

Secondary outcomes (1)

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

    excellent outcome at 90 days

    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 posted26 Aug 2020
  2. Study start1 Jul 2016
  3. Primary completion15 Mar 2020
  4. Study completion20 Jun 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A prospective, non-randomized, controlled, outcome-blinded study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04526756
Sponsor's protocol ID
2016-DFNE-002
Status last verified
Aug 2020
First submitted
22 Aug 2020
Last updated
26 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30355094

  • 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.

    PubMed 28384632

  • 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.

    PubMed 29724764

  • 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.

    PubMed 29089458

  • 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.

    PubMed 28768820

  • 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.

    PubMed 30617997

  • 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.

    PubMed 34777207

Questions about this trial

What is this clinical trial studying?

A study testing Mechanical Thrombectomy in people with Ischemic Stroke and Acute Stroke, run by Shanghai East Hospital at 1 site in China.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Aug 2020. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

modified Rankin Scale(mRS) score of 0 to 2 (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 NCT04526756, which also lists 7 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 26 Aug 2020.

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