Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window
NCT ID: NCT04256096
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
376 participants
INTERVENTIONAL
2020-03-09
2022-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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thrombectomy
mechanical thrombectomy with stent-retriever and/or thromboaspiration
Thrombectomy
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Clinical treatment
Best Medical treatment
Thrombectomy
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Interventions
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Thrombectomy
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. No significant pre-stroke functional disability (mRS ≤2)
3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
4. Age ≥18 years (no upper age limit)
5. Occlusion (TICI 0-1) of the intracranial ICA (distal ICA or T occlusions) and/or MCA-M1 segment suitable for endovascular treatment, as evidenced by CTA, MRA or angiogram, with or without concomitant cervical carotid occlusion or stenosis.
6. The presence of Age-Adjusted modified Clinical ASPECTS Mismatch (mCAM) defined as ASPECTS 5-10 and one of the following criteria:
1. NIHSS ≥ 8 and \>50% involvement in 0-1 Cortical (e.g. M1-6) ASPECTS areas (any age);
2. NIHSS ≥ 8 and \>50% involvement in 0-2 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old);
3. NIHSS ≥ 15 and \>50% involvement in 0-3 Cortical (e.g. M1-6) ASPECTS areas (and age \< 80 years old).
7. Patient treatable within 6-24 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as arterial puncture.
8. Informed consent obtained from patient or acceptable patient surrogate
Exclusion Criteria
1. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
2. Baseline platelet count \< 30.000/µL
3. Baseline blood glucose of \< 50mg/dL
4. Severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg) NOTE: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA guidelines recommended medication (including iv antihypertensive drips), the patient can be enrolled.
5. Patients in coma defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
6. Seizures at stroke onset which would preclude obtaining a baseline NIHSS
7. Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
8. History of life-threatening allergy (more than rash) to contrast medium
9. Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms
10. Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
11. Subject participating in a study involving an investigational drug or device that would impact this study.
12. Cerebral vasculitis
13. Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
14. Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
\- Neuroimaging criteria
15. Hypodensity on CT or restricted diffusion on MRI amounting to an ASPECTS score of \<5.
16. Complete involvement of more than 3 cortical ASPECTS areas (e.g. M1, M2, M3, M4, M5, or M6).
17. Complete absence of leptomeningeal collaterals on CT angiography (e.g. Malignant CTA pattern or score 0).
18. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
19. Significant mass effect with midline shift.
20. Evidence of ipsilateral carotid occlusion, high grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery that cannot be treated or will prevent access to the intracranial clot or excessive tortuosity of cervical vessels precluding device delivery/deployment
21. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
22. Evidence of intracranial tumor (except small meningioma).
18 Years
ALL
No
Sponsors
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Hospital das Clínicas de Ribeirão Preto
OTHER
Hospital Geral de Fortaleza
OTHER_GOV
Hospital de Base
OTHER
Federal University of São Paulo
OTHER
Fundação Faculdade Regional de Medicina de São José do Rio Preto
OTHER
UPECLIN HC FM Botucatu Unesp
OTHER
University of Campinas, Brazil
OTHER
Irmandade Santa Casa de Misericórdia de Porto Alegre
OTHER
Universidade Federal do Paraná
OTHER
Hospital Estadual Central
UNKNOWN
Hospital Sao Jose do Avai
UNKNOWN
Irmandade da Santa Casa de Misericordia de Sao Paulo
OTHER
Federal University of Uberlandia
OTHER
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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SHEILA CRISTINA OURIQUES MARTINS
Principal Investigator
Principal Investigators
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Raul G Nogueira, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Sheila CO Martins, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clinicas de Porto Alegre
Locations
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Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Associacao Congregacao de Santa Catarina
Vitória, Espírito Santo, Brazil
Hospital de Base
Brasília, Federal District, Brazil
Hospital das Clínicas de Uberlândia
Uberlândia, Minas Gerais, Brazil
Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, Brazil
Conferencia Sao jose do Avai
Itaperuna, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Hospital de Clínicas - UNICAMP
Campinas, São Paulo, Brazil
Hospital das Clinicas de Ribeirao Preto
Ribeirão Preto, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina S J Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual de Sao Paulo
São Paulo, São Paulo, Brazil
Universidade Federal de São Paulo - UNIFESP/EPM
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Roaldsen MB, Lindekleiv H, Mathiesen EB. Intravenous thrombolytic treatment and endovascular thrombectomy for ischaemic wake-up stroke. Cochrane Database Syst Rev. 2021 Dec 1;12(12):CD010995. doi: 10.1002/14651858.CD010995.pub3.
Other Identifiers
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17877519.6.1001.5327
Identifier Type: -
Identifier Source: org_study_id
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