The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System

Study Overview
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Brief Summary
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The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.

Detailed Description
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Each year 17 million people suffer stroke worldwide. According to the World Stroke Organization, stroke has become the second cause of death and disability worldwide. In the United States, every year, more than 795,000 people have a stroke. Given the large-scale challenges of curing stroke, prevention and treatments for stroke are much needed. Ischemic stroke is treatable in many patients if they have early access to viable treatments. This trial is a prospective, multicenter, open-label, single-arm trial designed to assess the potential treatment benefits of using the Imperative Care 0.088 Catheters in conjunction with the other devices in the Zoom Reperfusion System to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Zoom Reperfusion System includes the Imperative Care 0.088 Catheters, the Zoom Reperfusion Catheters (0.035 to 0.071 Catheters), Zoom Aspiration Tubing, and Zoom Aspiration Pump. The trial will assess reperfusion success using the mTICI scores in the absence of any rescue therapy, reperfusion time, first-pass success, and functional independence including a quality-of-life assessment.

Official Title
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A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients

Conditions
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Ischemic Stroke, Acute Stroke

Intervention / Treatment
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* Device: Zoom Reperfusion System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older NIHSS >=6 The operator feels that the stroke can be treated with endovascular thrombectomy approaches and the interventionalist estimates that groin puncture can be achieved within 8 hours from time last seen well Pre-event mRS scale 0-1 Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidenced by MRA or CTA For strokes in anterior circulation, ASPECTS >=6; For strokes in posterior circulation, pc-ASPECTS >=8 Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating stroke center or outside medical facility within 2 hours of treatment initiation If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible Consenting requirements met according to local IRB or Ethics Committee Exclusion Criteria: Female known to be pregnant at time of admission Patient has suffered a stroke in the past 3 months Presence of an existing or pre-existing large territory infarction Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor Known history of severe contrast allergy or absolute contraindication to iodinated contrast Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic Life expectancy of less than 6 months prior to stroke onset Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories Subject participating in another clinical trial involving an investigational device or drug Known cancer with metastases Evidence of active systemic infection Any known hemorrhagic or coagulation deficiency Imaging Exclusion Criteria: Evidence of intracranial hemorrhage on CT/MRI CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088 ID Catheters Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician Significant mass effect with midline shift as confirmed on CT/MRI Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, open-label with independent outcome assessments.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zoom Reperfusion System<br>The subject will undergo the endovascular thrombectomy procedure under general anesthesia or conscious sedation. The Imperative Care .088 Catheter will be used to gain access to the vasculature and direct aspiration of the clot will be attempted where feasible. The Zoom Reperfusion System must be the initial and primary device used to remove thrombus. | Device: Zoom Reperfusion System<br>* Thrombectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint | Rate of reperfusion success, defined as achieving mTICI score ≥ 2b flow with the Zoom Reperfusion System (primary treatment modality) without using additional thrombectomy devices or rescue therapy. | Intraprocedural | 
| Primary Safety Endpoint | Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging | 24-hour post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achieve mTICI score ≥ 2b | The time from groin puncture to mTICI score ≥ 2b flow | Intraprocedural | 
| Rate of mTICI score 3 reperfusion | The proportion of patients achieving mTICI score 3 flow | Intraprocedural | 
| First pass success | The proportion of patients where the mTICI score ≥ 2b reperfusion was accomplished with the first pass | Intraprocedural | 
| Rate of mTICI score 2c reperfusion | The proportion of patients achieving mTICI score ≥ 2c flow | Intraprocedural | 
| Functional Independence | The proportion of patients achieving Modified Rankin Scale (mRS) ≤2 using the primary treatment modality | 90 days post-procedure | 
| Quality of Life Assessment | Measured by Stroke Impact Scale (SIS) Questionnaire | 90 days post-procedure | 
| Mortality | All-cause mortality | 90 days post-procedure | 
| Intracranial hemorrhage (ICH) | All ICH, as confirmed by imaging | 24-hour post-procedure | 
| Embolization in new territory (ENT) | Emboli observed immediately after thrombectomy and in a previously unaffected territory | Intraprocedural | 
| Serious adverse device effects (SADEs) | All SADEs | 90 days post-procedure | 
| Serious adverse events | All serious adverse events | 90 days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS