Post Marketing Study to Evaluate the NIMBUS Device

Study Overview
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Brief Summary
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A post-market study evaluating the NIMBUS Device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

Detailed Description
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The objective of this study is to assess the efficacy of the NIMBUS Device. The study will also report on clot characteristics and clinical outcomes.

Official Title
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Post Marketing Study of Patients to Evaluate NIMBUS Revascularization Effectiveness With Challenging Occlusions

Conditions
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Cerebral Stroke

Intervention / Treatment
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* Device: NIMBUS Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 The subject or the subject's legally authorized representative has signed and dated an Informed Consent Form. Patient has had one or two passes of another mechanical thrombectomy device without achieving mTICI 2b or better and continues to have angiographic confirmation of a Large Vessel Occlusion (LVO) in the same vessel. mRS 0-1 prior to this stroke. NIMBUS is used on the second or third overall pass to attempt revascularization. Exclusion Criteria: Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. Confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication). All patients with severe hypertension on presentation (SBP > 220 mmHg and/or DBP > 120 mm Hg). All patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (SBP >185 mmHg and/ or DBP >110 mmHg). Known cerebral vasculitis. Known cancer with life expectancy less than 12 months. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion. Intracranial stenosis that prevents access to the site of occlusion. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor (except small meningioma). Evidence of dissection in the extra or intracranial cerebral arteries. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mechanical Thrombectomy<br>NIMBUS Device | Device: NIMBUS Device<br>* NIMBUS Geometric Clot Extractor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Successful Revascularization With NIMBUS Device | Successful revascularization was defined as achieving an modified thrombolysis in cerebrovascular infarction (mTICI) score of 2b or greater as determined by an Independent Core Laboratory. The expanded treatment in cerebral infarction (eTICI) score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent (%) filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in [90-99%] of downstream territory; 3=Complete and 100% reperfusion. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Successful Procedural Revascularization | Successful procedural revascularization was defined as achieving an mTICI score of 2b or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in [67-89%] of downstream territory); 2c=Reperfusion in [90-99%] of downstream territory; 3=Complete and 100% reperfusion. | Day 1 | 
| Percentage of Participants With Excellent Procedural Revascularization | Excellent procedural revascularization was defined as achieving an mTICI score of 2c or greater at the end of procedure as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in [67-89%] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion. | Day 1 | 
| Percentage of Participants With First Pass Revascularization Using NIMBUS Device | First Pass revascularization was defined as achieving an mTICI score of 2b or greater after the first use of NIMBUS device as determined by an Independent Core Laboratory. The eTICI score was a modified from the mTICI scale. eTICI was a 6-point grading system for determining the response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0% filling of the downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in [50-66%] of downstream territory) and 2b67 (reperfusion in [67-89%] of downstream territory); 2c=Reperfusion in (90-99%) of downstream territory; 3=Complete and 100% reperfusion. | Day 1 | 
| Percentage of Participants With Embolization to a New Territory (ENT) | Percentage of participants with ENT was reported. | Day 1 | 
| Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH) According to the Heidelberg Bleeding Classification (HBC) | Percentage of participants with sICH according to the HBC was reported. sICH was defined as new intracranial hemorrhage detected by brain imaging associated with any of the item: greater than or equal to (>=) 4 points total National Institute of Health Stroke Scale (NIHSS) at the time of diagnosis compared to immediately before worsening; >=2 point in one NIHSS category. The rationale for this was to capture new hemorrhages that produce new neurological symptoms, making them clearly symptomatic but not causing worsening in the original stroke territory; leading to intubation/hemicraniectomy/external ventricular drain (EVD) placement or other major medical/surgical intervention; absence of alternative explanation for deterioration. | Day 1 | 
| Number of Participants With All-Cause Mortality | Number of participants with all-cause mortality at 90 days post-procedure on Day 0 was reported. All-cause mortality included all deaths of participants due to any cause. | Up to Day 90 | 
| Percentage of Participants With Modified Rankin Scale (mRS) Score of Less Than or Equal to (<=) 2 | Percentage of participants with mRS score of <=2 was reported. The mRS was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death. | Up to Day 90 |