Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window (RESILIENTExt)
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ClinicalTrials.gov Identifier: NCT04256096 |
Recruitment Status : Unknown
Verified February 2021 by SHEILA CRISTINA OURIQUES MARTINS, Hospital de Clinicas de Porto Alegre.
Recruitment status was: Recruiting
First Posted : February 5, 2020
Last Update Posted : February 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Stroke, Ischemic | Device: Thrombectomy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 376 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators. For the primary endpoint, subjects will be followed for 90 days post-randomization. Distribution of the modified Rankin Scale scores at 90 days will be evaluated by two separate assessors who are blinded to treatment. Primary Endpoint will consider central core lab readings only (video interview with RFA method) with local reading as a back-up mechanism. |
Primary Purpose: | Treatment |
Official Title: | Randomization of Endovascular Treatment With Stent-retriever and/or Thromboaspiration vs. Best Medical Therapy in Acute Ischemic Stroke Due to Large VEssel OcclusioN Trial in the Extended Time Window |
Actual Study Start Date : | March 9, 2020 |
Estimated Primary Completion Date : | February 1, 2022 |
Estimated Study Completion Date : | May 1, 2022 |

Arm | Intervention/treatment |
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Experimental: thrombectomy
mechanical thrombectomy with stent-retriever and/or thromboaspiration
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Device: Thrombectomy
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Other Name: Endovascular treatment |
Active Comparator: Clinical treatment
Best Medical treatment
|
Device: Thrombectomy
Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
Other Name: Endovascular treatment |
- Modified Rankin Scale scores [ Time Frame: 90 days ]Distribution of the modified Rankin Scale scores at 90 days (shift analysis). The score range from zero to 6 with higher values indicating a worst functional outcome at 90 days
- Proportion of Patients with Functional independence in 90 days [ Time Frame: 90 days ]Functional independence defined as mRS ≤2
- Disability on the utility-weighted modified Rankin scale (UW-mRS) [ Time Frame: 90 days ]Mean score for disability on the utility-weighted modified Rankin scale (UW-mRS). The score range from 1 to zero with higher values indicating a better functional outcome at 90 days
- Quality of life measured by EuroQol Group 5-Dimension Self-Report Questionnaire (EuroQol / EQ5D) [ Time Frame: 90 days and 1 year ]Quality of life analysis as measured by EuroQol/EQ5D 5-Dimension Self-Report Questionnaire, on which scores range from -0.176 to 1, with higher values indicating a better quality of life]) at 90 days
- Mortality at 90 days [ Time Frame: 90 days ]Mortality at 90 days
- Proportion of patients with Intracranial Hemorrhage at 24 hours [ Time Frame: 24 hours ]Clinically significant ICH rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the Heidelberg criteria. Symptomatic ICH will be defined as per the SITS-MOST definition: deterioration in NIHSS score of ≥4 points within 24 hours from treatment and evidence of intraparenchymal hemorrhage type 2 in the 22 to 36 hours follow-up imaging scans.
- Procedural related complications [ Time Frame: immediately after procedure ]Procedural related complications: arterial perforation, arterial dissection, and embolization in a previously uninvolved vascular territory

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment or the treatment is contraindicated (e.g., subject presents beyond recommended time from symptom onset), or where patient has received IV thrombolytic therapy without clinical improvement.
- No significant pre-stroke functional disability (mRS ≤2)
- Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points (assessed within one hour prior to qualifying imaging)
- Age ≥18 years (no upper age limit)
- 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.
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The presence of Age-Adjusted modified Clinical ASPECTS Mismatch (mCAM) defined as ASPECTS 5-10 and one of the following criteria:
- NIHSS ≥ 8 and >50% involvement in 0-1 Cortical (e.g. M1-6) ASPECTS areas (any age);
- NIHSS ≥ 8 and >50% involvement in 0-2 Cortical (e.g. M1-6) ASPECTS areas (and age < 80 years old);
- NIHSS ≥ 15 and >50% involvement in 0-3 Cortical (e.g. M1-6) ASPECTS areas (and age < 80 years old).
- 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.
- Informed consent obtained from patient or acceptable patient surrogate
Exclusion Criteria:
-Clinical criteria
- Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR > 3.0
- Baseline platelet count < 30.000/µL
- Baseline blood glucose of < 50mg/dL
- 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.
- 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).
- Seizures at stroke onset which would preclude obtaining a baseline NIHSS
- Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
- History of life-threatening allergy (more than rash) to contrast medium
- Subjects who has received IV t-PA treatment beyond 4.5 hours from the beginning of the symptoms
- Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
- Subject participating in a study involving an investigational drug or device that would impact this study.
- Cerebral vasculitis
- 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.)
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Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
- Neuroimaging criteria
- Hypodensity on CT or restricted diffusion on MRI amounting to an ASPECTS score of <5.
- Complete involvement of more than 3 cortical ASPECTS areas (e.g. M1, M2, M3, M4, M5, or M6).
- Complete absence of leptomeningeal collaterals on CT angiography (e.g. Malignant CTA pattern or score 0).
- CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed).
- Significant mass effect with midline shift.
- 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
- Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
- Evidence of intracranial tumor (except small meningioma).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04256096
Contact: Sheila CO Martins, MD, PhD | 51999628467 | scmartins@hcpa.edu.br | |
Contact: Natacha Fleck | 51992699829 | pesquisaneurovascular@gmail.com |
Brazil | |
Hospital Geral de Fortaleza | Recruiting |
Fortaleza, Ceara, Brazil | |
Contact: Fabricio Lima, PhD 85999982150 fabricio.lima.neuro@gmail.com | |
Hospital de Base | Recruiting |
Brasília, DF, Brazil | |
Contact: Leticia C Rebello, MD 61999150626 letirebello@gmail.com | |
Associacao Congregacao de Santa Catarina | Recruiting |
Vitória, Espirito Santo, Brazil, 29050-335 | |
Contact: Jose A Fiorot Jr, PhD 27992778579 fiorotjr@gmail.com | |
Hospital das Clínicas de Uberlândia | Recruiting |
Uberlândia, Minas Gerais, Brazil | |
Contact: Jullyanna Shinosaki, MD +553491161478 jsm_shinosaki@yahoo.com.br | |
Hospital de Clínicas da Universidade Federal do Paraná | Not yet recruiting |
Curitiba, Parana, Brazil | |
Contact: Viviane F Zetola 0154199761660 viviane.zetola@gmail.com | |
Conferencia Sao jose do Avai | Not yet recruiting |
Itaperuna, RJ, Brazil | |
Contact: Ivete itaperuna P Goncalves 22988315201 ipilloster@gmail.com | |
Hospital de Clinicas de Porto Alegre | Recruiting |
Porto Alegre, RS, Brazil, 90035007 | |
Contact: Natacha Fleck 51992699829 pesquisaneurovascular@gmail.com | |
Contact: Ana Julia Lehnen 51992870762 anajlehnen@gmail.com | |
Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA | Not yet recruiting |
Porto Alegre, RS, Brazil | |
Contact: Alexandre Maulaz 51992826915 maulaz@terra.com.br | |
Hospital das Clínicas da Faculdade de Medicina de Botucatu | Not yet recruiting |
Botucatu, SP, Brazil | |
Contact: Rodrigo Bazan, PhD 14981157727 bazan.r@terra.com.br | |
Hospital de Clínicas - UNICAMP | Not yet recruiting |
Campinas, SP, Brazil | |
Contact: Fabricio B Cardoso, MD 019981254952 fabriciobuchdid@hotmail.com | |
Hospital das Clinicas de Ribeirao Preto | Recruiting |
Ribeirão Preto, SP, Brazil | |
Contact: Octavio M Pontes-Neto, PhD 16981013465 ompneto@gmail.com | |
Fundacao Faculdade Regional de Medicina S J Rio Preto | Not yet recruiting |
São José Do Rio Preto, SP, Brazil | |
Contact: Raquel Hidalgo, MD 17997640004 draquelhidalgo@gmail.com | |
Instituto de Assistência Médica ao Servidor Público Estadual de Sao Paulo | Not yet recruiting |
São Paulo, SP, Brazil | |
Contact: André Rezende, MD +5511981359842 andrerezende@neurointervencao.com.br | |
Universidade Federal de São Paulo - UNIFESP/EPM | Not yet recruiting |
São Paulo, SP, Brazil | |
Contact: Gisele S Silva, PhD giselesampaio@hotmail.com |
Principal Investigator: | Raul G Nogueira, MD | Emory University | |
Principal Investigator: | Sheila CO Martins, MD, PhD | Hospital de Clinicas de Porto Alegre |
Responsible Party: | SHEILA CRISTINA OURIQUES MARTINS, Principal Investigator, Hospital de Clinicas de Porto Alegre |
ClinicalTrials.gov Identifier: | NCT04256096 |
Other Study ID Numbers: |
17877519.6.1001.5327 |
First Posted: | February 5, 2020 Key Record Dates |
Last Update Posted: | February 10, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigators |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | after de publication for 6 months |
Access Criteria: | Because of the sensitive nature of the data collected for this study, requests to access the dataset from qualified researchers trained in human subject confidentiality protocols may be sent to the principal investigators |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
stroke ischemic stroke thrombectomy treatment acute stroke |
Stroke Ischemic Stroke Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |