Amnis Therapeutics Thrombectomy Device-First in Man (FIM) Safety and Performance Study

Not yet recruiting

Phase N/A Results N/A

Trial Description

Prospective, single-arm, open label, Safety and Performance clinical investigation.

Detailed Description

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.

Conditions

Interventions

  • 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.

Outcomes

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.

Sponsors