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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.
Full description
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.
Enrollment
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Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
328 participants in 1 patient group
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Central trial contact
Pojai Phattanagosai; Didem Aksoy
Data sourced from clinicaltrials.gov
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