The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
Purpose
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.
Conditions
- Ischemic Stroke
- Acute Stroke
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 18 and older 2. NIHSS >=6 3. 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 4. Pre-event mRS scale 0-1 5. 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 6. For strokes in anterior circulation, ASPECTS >=6; For strokes in posterior circulation, pc-ASPECTS >=8 7. 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 8. If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible 9. Consenting requirements met according to local IRB or Ethics Committee
Exclusion Criteria
- Female known to be pregnant at time of admission 2. Patient has suffered a stroke in the past 3 months 3. Presence of an existing or pre-existing large territory infarction 4. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor 5. Known history of severe contrast allergy or absolute contraindication to iodinated contrast 6. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic 7. Life expectancy of less than 6 months prior to stroke onset 8. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories 9. Subject participating in another clinical trial involving an investigational device or drug 10. Known cancer with metastases 11. Evidence of active systemic infection 12. Any known hemorrhagic or coagulation deficiency Imaging Exclusion Criteria: 13. Evidence of intracranial hemorrhage on CT/MRI 14. CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access 15. Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088" ID Catheters 16. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices 17. 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 18. Significant mass effect with midline shift as confirmed on CT/MRI 19. Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI 20. Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Prospective, multicenter, open-label with independent outcome assessments.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Reperfusion will be graded by an independent core lab that is not an enrolling investigational site. Neurological Outcome Assessors (NIHSS assessment): Neurological outcome assessors who will perform post-procedure 24-hour NIHSS assessments are NIHSS certified team members not performing the thrombectomy procedure and with no financial conflict of interest with Imperative Care, Inc. Functional Outcome Assessors (mRS assessment): Functional outcome assessors who will perform post-procedure assessments are part of achieving unbiased study objectives. They will not have access to patient data.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Zoom Reperfusion System |
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. |
|
Recruiting Locations
Houston, Texas 77007
More Details
- Status
- Recruiting
- Sponsor
- Imperative Care, Inc.
Detailed 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.