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Enrolling By Invitation
NCT05667103
The Safety and Efficacy of Embotrap Ⅱ in Treating Patients With Acute Ischemic Stroke
Conditions: Stroke, Acute Ischemic Stroke
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 330
Sponsor: Xuanwu Hospital, Beijing
Location: China
Summary
This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of EmboTrap II with other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO).
All enrolled patients will be followed up at 90 days after randomization.
Eligibility Criteria
Inclusion Criteria:Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.Premorbid mRS 0-2Ages 18-80 yearsNIHSS ≥6 at admissionThe time from onset to groin puncture ≤ 24 hoursASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)Informed consent approved by patients or acceptable patient surrogate.Exclusion Criteria:Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS < 6 points, core infarct volume ≥ 70mL or core infarct area >1/3 middle cerebral artery territory).Severe allergy to contrast media allergy and nitinolRefractory hypertension (SBP > 185 mmHg or DBP > 110 mmHg)Platelet count < 30 x 10^9 / LCoagulopathy history or hemorrhage disorders diseaseConcurrent participation in a study involving an investigational drug or device that would impact the current studyEvidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomyUnable to complete the study and follow-up due to mental disorders, cognitive or emotional disordersPregnant or lactating womenAnticipated life expectancy < 6 monthsPatients without a legally authorized representative to sign the consent formFor other reasons, the researchers believe that the patient is not suitable for enrollment
Source: ClinicalTrials.gov (NCT05667103). StuddyBuddy aggregates publicly available trial information.