The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
342
Mechanical thrombectomy and adjunct stentiing
Mechanical thrombectomy only
Primary Efficacy Endpoint
• Utility weighted 90-day Modified Rankin Score (mRS)
Time frame: 90 (+/- 30) days post treatment
Primary Safety Endpoint
Rate of symptomatic intracranial hemorrhage (sICH: Parenchymal hematoma Type 2 (PH2) with ≥4 points NIHSS worsening) at 24 hours (-12/+16 hours) from randomization)
Time frame: 90 (+/- 30 ) days post treatment
Secondary Safety Endpoint
Any neurological deterioration with ≥4 points worsening on NIHSS before discharge and unrelated to sICH or sedation (In addition to the routine 24-hour CT/Magnetic Resonance Imaging (MRI) scan, repeat neuroimaging is mandatory for any subsequent neurological deterioration at any time during hospitalization).
Time frame: 8 (+/- 3) days or Discharge post treatment
Secondary Safety Endpoint
Embolization into new territory (ENT)
Time frame: Immediate post treatment
Secondary Safety Endpoint
Distal embolization (DE)
Time frame: Immediate post treatment
Secondary Safety Endpoint
Major vessel injury (perforation, dissection)
Time frame: Immediate post treatment
Secondary Safety Endpoint
Ipsilateral recurrent stroke in the territory of the index artery from Day 1 through 1-year
Time frame: 1 year (+/- 60) days post treatment
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Secondary Safety Endpoint
Rates of stent re-stenosis and stent thrombosis at the end of endovascular procedure
Time frame: Immediate post treatment
Secondary Safety Endpoint
• Intracranial stent stenosis (WASID) and stent thrombosis at any time between Day 1 to one year follow up
Time frame: 1 year (+/- 60) days post treatment
Secondary Safety Endpoint
Intracranial reintervention between Day 1 through 1-year (Any intervention or reintervention will be captured during that period)
Time frame: 1 year (+/- 60) days post treatment
Secondary Safety Endpoints
Neurological and All-Cause Mortality at 90 days and 1-year
Time frame: 1 year (+/- 60) days post treatment
Secondary Safety Endpoint
All serious adverse events (SAE), including serious adverse device events (SADE), serious adverse procedural events (SAPE), and unanticipated SAE.
Time frame: 1 year (+/- 60) days post treatment