Randomization of Endovascular Treatment in Acute Ischemic Stroke in the Extended Time Window
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stroke Ischemic
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management aloneMasking: 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
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterio...
Prospective, multi-center, randomized, controlled, open-label, blinded-endpoint trial with a sequential design. The randomization employs a 1:1 ratio of mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone in patients who suffer a large vessel anterior circulation ischemic stroke between 8 and 24 hours from time last seen well. Randomization will be done under a minimization process using age (?68 vs. >68 years), baseline NIHSS (<17 v. ?17), ASPECTS (5-7 vs. 8-10), therapeutic window (6-12 or 12-24 hours after TLKW), occlusion site (Intracranial ICA or M1), and clinical site. For the primary endpoint, subjects will be followed for 90 days post-randomization. Sham endovascular procedure has been rejected due to the medical risk of the angiography and practical issues that difficult to maintain blindness of investigators.
Tracking Information
- NCT #
- NCT04256096
- Collaborators
- Hospital de Base
- Hospital das Clínicas de Ribeirão Preto
- Hospital Geral de Fortaleza
- Federal University of São Paulo
- Irmandade da Santa Casa de Misericordia de Sao Paulo
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
- UPECLIN HC FM Botucatu Unesp
- Federal University of Uberlandia
- University of Campinas, Brazil
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Universidade Federal do Paraná
- Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
- Hospital Estadual Central
- Hospital Sao Jose do Avai
- Investigators
- Principal Investigator: Raul G Nogueira, MD Emory University Principal Investigator: Sheila CO Martins, MD, PhD Hospital de Clinicas de Porto Alegre
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