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

Imperative Care

Status: Completed

Conditions: Ischemic Stroke; Acute Stroke

Treatments: Device: Zoom Reperfusion System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04129125

ICI-001

Details and patient eligibility

About

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: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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328 participants in 1 patient group

Zoom Reperfusion System

Experimental group

Description:

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.

Treatment:

Device: Zoom Reperfusion System