Stroke Clinical Trial
— RESILIENTOfficial 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
Verified date | February 2020 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, multi-center, randomized, controlled, open, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stentriever and/or Thromboaspiration versus medical management alone. Randomization will be done under a minimization process using age, baseline NIHSS, use of IV tpa, vessel occlusion site and hospital. To evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving more favorable outcomes in the distribution of the modified Rankin Scale scores at 90 days in subjects presenting with acute large vessel ischemic stroke <8 hours from symptom onset. Subjects are either ineligible for IV alteplase or have received IV alteplase therapy without recanalization. Sample size is projected to be 690 patients for a difference in treatment effect of 10%.
Status | Completed |
Enrollment | 221 |
Est. completion date | June 30, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 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. 2. No significant pre-stroke functional disability (mRS = 1) 3. Baseline NIHSS score obtained prior to randomization must be equal or higher than 8 points 4. Age =18 years 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. Patient treatable within eight 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 groin puncture. 7. 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 or > 400mg/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 (NIHSS item of consciousness >1) (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 lactating 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 =1. 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). 15. Hypodensity on CT or restricted diffusion amounting to an ASPECTS score of <6 on NCCT, or <5 on DWI MRI. The use of CTP or MRI perfusion is optional. 16. Collaterals with malignant profile on CTA (without colateral circulation on CTA) 17. CT or MR evidence of hemorrhage (the presence of GRE microbleeds is allowed). 18. Significant mass effect with midline shift. 19. 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 20. Subjects with occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) 21. Evidence of intracranial tumor (except small meningioma). |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital das Clínicas da Faculdade de Medicina de Botucatu | Botucatu | São Paulo |
Brazil | Hospital de Base do Distrito Federal | Brasília | DF |
Brazil | Hospital de Clínicas - UNICAMP | Campinas | São Paulo |
Brazil | Hospital de Clínicas da Universidade Federal do Paraná | Curitiba | Paraná |
Brazil | Hospital Governador Celso Ramos | Florianópolis | SC |
Brazil | Hospital Geral de Fortaleza/SUS | Fortaleza | Ceará |
Brazil | Hospital São José do Avaí | Itaperuna | Rio De Janeiro |
Brazil | Clinica Neurologica e Neurocirurgica de Joinville S/S Ltda | Joinville | Santa Catarina |
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Brazil | UNIÃO BRASILEIRA DE EDUCAÇÃO E ASSISTENCIA, Hospital São Lucas PUCRS | Porto Alegre | Rio Grande Do Sul |
Brazil | Hospital de Clínicas de Ribeirão Preto | Ribeirão Preto | São Paulo |
Brazil | Hospital Geral Roberto Santos | Salvador | Bahia |
Brazil | Irmandade da Santa Casa de Misericórdia | São Paulo | SP |
Brazil | Universidade Federal de São Paulo - UNIFESP/EPM | São Paulo | |
Brazil | Hospital Estadual Central | Vitória | Espírito Santo |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Brainomix Limited, iSchemaView, Inc, Medtronic, Ministry of Health, Brazil, Penumbra Inc. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Distribution of the modified Rankin Scale scores (shift analysis) | Distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors who are blinded to treatment | 90 days | |
Secondary | Functional independence (modified Rankin Score = 2) | Functional independence measured by modified Rankin Score = 2 in 90 days in both groups | 90 days | |
Secondary | Infarct Burden at 24 hours | ASPECTS change from baseline to 24 hours on CT or MRI | 24 hours | |
Secondary | Dramatic early favorable response | defined as an NIHSS score 0-2 or a NIHSS score decrease of =8 from baseline at 24 hours | 24 hours | |
Secondary | Cost effectiveness | Cost effectiveness analysis of interventional therapy vs medical therapy alone | Life-time horizon perspective | |
Secondary | Quality of life analysis | Quality of life analysis as measured by EuroQol/EQ5D at 3 month, 6 months and one year, between interventional therapy vs medical therapy alone | 3 months, 6 months, 1 year | |
Secondary | Vessel recanalization at 24 hours | Vessel recanalization evaluated by CT angiography (CTA) or MR angiography (MRA) at 24 hours in both treatment groups | 24 hours | |
Secondary | Successful recanalization at the end of procedure | defined as a grade of 2b or 3 (indicating reperfusion of >50% of the affected territory) on the modified Thrombolysis in Cerebral Infarction (mTICI) scale | immediatelly after procedure (only thrombectomy arm) | |
Secondary | Mortality | Mortality at 90 days | 90 days | |
Secondary | Symptomatic Intracranial hemorrhage | Clinically significant Intracranial hemorrhage (ICH) rates at 24 (-2/+12) hours. All intracerebral hemorrhages will be classified by a central core-lab using the ECASS criteria for CT evaluation. 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. The incidence of any asymptomatic hemorrhage measured at 24 (-2/+12) hours will also be compared | 24 hours | |
Secondary | Procedure related complications | Complications occurring during the procedure will be evaluated: distal embolization in a new territory, arterial dissection, arterial perfuration, groin hematoma | During the procedure |
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