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

ID#: NCT04129125

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: September 01, 2021

End Date: September 01, 2023

Contact Information:
Pojai Phattanagosai
1.669.228.3908
Lilach Ofri
1.408.483.3994
Summary: 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.
Eligibility:

Inclusion Criteria:

1. 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, IV t-PA should be administered as soon as possible, but no later than 3 hours from onset of stroke symptoms (onset time is defined as the last time when the patient was witnessed to be at baseline)

9. Consenting requirements met according to local IRB or Ethics Committee

Exclusion Criteria:

1. 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