ACTRN12619000890134
Recruiting
未知
A Prospective, Single-arm, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPointTM Reperfusion SystemTM for Aspiration Embolectomy in Acute Ischemic Stroke Patients
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Route 92 Medical, Inc.
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The consent process has been completed with the subject, Legally Authorized Representative, or two physician best interest and consent is documented
- •2\.Age \>\=18 years
- •3\.Clinical signs consistent with an acute ischemic stroke
- •4\.Baseline National Institutes of Health Stroke Scale (NIHSS) score ? 6
- •5\.Pre\-stroke modified Rankin Score (mRS) ? 2
- •6\.Acute occlusion of the middle cerebral artery (MCA), internal carotid artery (ICA), vertebral or basilar arteries confirmed via computed tomography angiography (CTA) and/or magnetic resonance angiography (MRA)
- •7\.The Investigator estimates that at least one delivery of the Route 92 Medical Reperfusion System can be completed within 24 hours of time last known well
- •8\.In the opinion of the Investigator, reperfusion of the ischemic territory will result in clinical benefit
- •9\.Angiographic confirmation of an occlusion or near occlusion of the middle cerebral artery, internal carotid artery, vertebral or basilar arteries with a modified Thrombolysis In Cerebral Infarction (mTICI) scale score of 0\-1
Exclusion Criteria
- •1\.Known pregnancy or breast feeding
- •2\.Known comorbidity that may complicate treatment or prevent improvement or follow\-up
- •3\.Known life expectancy \< 12 months
- •4\.Known history of severe allergy to contrast medium
- •5\.Subject known to have suffered a stroke in the past 90 days
- •6\.Subject participating in another study involving an investigational device or drug.
- •7\.Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, fibromuscular dysplasia, Ehlers\-Danlos syndrome)
- •8\.Any known pre\-existing hemorrhagic or coagulation deficiency
- •9\.Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage
- •10\.Baseline CT or MRI showing intracranial tumor (except small meningioma)
Outcomes
Primary Outcomes
Not specified
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