Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorProMedica Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 to 80 years of age
Presenting with symptoms consistent with AIS
Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling
NIHSS ≥ 6
Disqualifiers
Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
Midline shift or herniation
Evidence of intracranial hemorrhage
Trial design
Design model
Parallel
Treatments tested in this trial
Mechanical Thrombectomy plus adjunct stenting
Procedure/SurgeryMechanical thrombectomy and adjunct stentiing
Mechanical Thrombectomy
DeviceMechanical thrombectomy only
Treatment groups
342 Participants
are divided into 2 treatment groupsGroup A: Randomized to Mechanical Thrombectomy (MT) plus adjunct StentingExperimental treatment 1 intervention
Group B: Randomized to Mechanical Thrombectomy (MT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Primary Efficacy Endpoint
• Utility weighted 90-day Modified Rankin Score (mRS)
Time frame
90 (+/- 30) days post treatment2
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 treatmentSecondary outcomes
1
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 treatment2
Secondary Safety Endpoint
Embolization into new territory (ENT)
Time frame
Immediate post treatment3
Secondary Safety Endpoint
Distal embolization (DE)
Time frame
Immediate post treatment4
Secondary Safety Endpoint
Major vessel injury (perforation, dissection)
Time frame
Immediate post treatmentOther outcomes
1
Secondary Efficacy Endpoints
Utility weighted one-year Modified Rankin Score (mRS)
Time frame
1 year (+/-60) days post treatment2
Secondary Efficacy Endpoints
90-day and one-year mRS ordinal shift (mRS 5 and 6 combined)
Time frame
90 (+/-30) days post treatment3
Secondary Efficacy Endpoints
90-day and one-year dichotomized mRS 0-2 outcome
Time frame
1 year (+/- 60) days post treatment4
Secondary Efficacy Endpoints
90-day and one-year dichotomized mRS 0-3 outcome
Time frame
1 year (+/-60) days post treatmentSponsors and contacts
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Source ClinicalTrials.gov