CompletedNot Applicable

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

United States328 participantsStarted 2021-10-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. Female known to be pregnant at time of admission
. Patient has suffered a stroke in the past 3 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure

FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure

FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure

Trial details

NCT IDNCT04129125

SponsorImperative Care, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-28

Results submitted2025-05-28

View on ClinicalTrials.gov More Ischemic Stroke trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Exclusion criteria

. Female known to be pregnant at time of admission
. Patient has suffered a stroke in the past 3 months

What they're measuring

ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure

FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure

FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success

Timeframe: Intraprocedural

FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board

Timeframe: 24-hour post-procedure