Post-Market Registry on Use of Merci Retrieval System. Primary data to be collected will include:
- Post-procedure revascularization success
- 90-day mRS 0-2
- 90-day mortality
The Merci Registry is a prospective multicenter registry with up to 3000 patients enrolled at a maximum of 100 sites.
The registry requires use (at least one pass in the intracranial vasculature) of any Merci Retriever device (X Series, L Series, V Series) in the setting of acute ischemic stroke due to large vessel intracranial occlusion.
- Mechanical Thrombectomy (Merci Retriever)Device
Other Names: Penumbra system; TREVO; Solitaire Intervention Desc: Thrombectomy performed with the Merci Retriever in the setting of acute ischemic stroke. ARM 1: Kind: Experimental Label: Acute Ischemic Stroke patients Description: Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Mechanical Thrombectomy procedure.
- Concentric Merci Retrievers Other
Intervention Desc: Remove the clot by putting an FDA approved device through the clot and pulling it back to remove the attached clot into the tube and pulling it out of your body. If your doctor first attempts to remove the clot with such a device, you may still receive rt-PA if some of the clot is still present.
- Mechanical Embolectomy Procedure
Intervention Desc: Thrombectomy ARM 1: Kind: Experimental Label: Acute Ischemic Stroke patients Description: Patients presenting with signs and symptoms consistent with a diagnosis of Acute Ischemic Stroke, who are treated with the Merci Retrieval System during a Thrombectomy procedure.
- Observation: Cohort
- Perspective: Prospective
- Sampling: Probability Sample
All patients with ischemic stroke treated with a Merci Retriever either alone or in combination with adjunctive therapies such as lytics will be included in the Registry.
Patient assessed post-procedure for revascularization success, at 24 hours for change from baseline NIHSS, and at 90 day for mRS.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Post-procedure revascularization success; 90-day mRS 0-2; 90-day mortality rate.|
|Secondary||NIHSS change from baseline to 24-hours; length of hospital stay (# days); discharge disposition.|
|Primary||Post-procedure revascularization success||post-procedure||No|
|Primary||90-day mRS 0-2||90-day||No|
|Secondary||NIHSS change from baseline to 24-hours||24-hour||No|
|Secondary||90-day outcomes will be evaluated based on post-procedure revascularization status||90-day||No|
|Secondary||90-day mRS outcomes||90-day||Yes|