Prospective, single-arm, open label, Safety and Performance clinical investigation.
The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke. Pre-CE mark clinical investigation. Population will be subjects with documented untreated, acute ischemic stroke with large vessel occlusion.
Trial Stopped: Amnis supplier of wire coating is ceasing sale of this raw material due to relocation of their sub contractor's facilities. Amnis must replace the wire.
- Thrombectomy Device Device
Intervention Desc: The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke ARM 1: Kind: Experimental Label: Open arm Description: Thrombectomy device to be used to retrieve clot and restore blood flow.
|Type||Measure||Time Frame||Safety Issue|
|Primary||All serious adverse events (notably at 24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first).||24 hours ± 3 hrs post procedure or until alternative stroke treatment is initiated, whichever comes first.|
|Primary||All cause mortality (90 days).||3 months post-procedure|
|Secondary||Arterial recanalization of the occluded target vessel in the immediate post-procedure angiogram.||Immediate post-procedure angiogram.|
|Secondary||Proportion of patients with rapid neurological improvement as determined by a NIHSS ≤4.||First 24 hours after treatment|
|Secondary||Good functional clinical outcome as determine by a modified Rankin Scale score of 0-2.||First 24 hours after treatment.|
- Amnis Therapeutics Lead