Merci Registry - Real World Use of the Merci Retrieval System in Acute Ischemic Stroke

Completed

Phase 4 Results N/A

Trial Description

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

Detailed Description

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.

Conditions

Interventions

  • 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.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

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 Involvement

Patient assessed post-procedure for revascularization success, at 24 hours for change from baseline NIHSS, and at 90 day for mRS.

Outcomes

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
Primary 90-day mortality 90-day Yes
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 Discharge Disposition variable No
Secondary 90-day mRS outcomes 90-day Yes

Sponsors