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Completed

NCT Number: NCT04129125

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

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.

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Key information

Conditions

Ischemic Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radiology of Huntsville, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Consenting requirements met according to local IRB or Ethics Committee

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

Treatment and study plan

Zoom Reperfusion System

Device

Thrombectomy

Primary outcomes

  1. ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success

    Time frame: Intraprocedural

    Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

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

    Time frame: 24-hour post-procedure

    Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

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

    Time frame: Intraprocedural

    Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

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

    Time frame: 24-hour post-procedure

    Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

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

    Time frame: Intraprocedural

    Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

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

    Time frame: 24-hour post-procedure

    Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

Secondary outcomes

  1. ITT Cohort: Time to Achieve mTICI Score ≥ 2b

    Time frame: Intraprocedural

    The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

    mTICI range: 0 to 3; higher score means better reperfusion

  2. ITT Cohort: Rate of mTICI Score 3 Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better reperfusion

  3. ITT Cohort: Rate of First Pass Success

    Time frame: Intraprocedural

    Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

    mTICI range: 0 to 3; higher score means better outcome

  4. ITT Cohort: Rate of mTICI Score 2c Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better outcome

  5. ITT Cohort: Rate of Functional Independence

    Time frame: 90-days post-procedure

    The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

    The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death

  6. ITT Cohort: Quality of Life Assessment

    Time frame: 90 days post-procedure

    The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

  7. ITT Cohort: Rate of All-Cause Mortality

    Time frame: 90 days post-procedure

    Rate of 90-day all-cause mortality

  8. ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)

    Time frame: 24-hour post-procedure

    Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

  9. ITT Cohort: Rate of Embolization in New Territory (ENT)

    Time frame: 24-hour post-procedure

    Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

  10. ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)

    Time frame: 90 days post-procedure

    Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

  11. ITT Cohort: Rate of Serious Adverse Events

    Time frame: 90 days post-procedure

    All serious adverse events through 90 days post-procedure.

  12. FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b

    Time frame: Intraprocedural

    The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

    mTICI range: 0 to 3; higher score means better reperfusion

  13. FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better outcome

  14. FDA Clearance Cohort: Rate of First Pass Success

    Time frame: Intraprocedural

    Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

    mTICI range: 0 to 3; higher score means better outcome

  15. FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better reperfusion

  16. FDA Clearance Cohort: Rate of Functional Independence

    Time frame: 90-days post-procedure

    The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

    The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

  17. FDA Clearance Cohort: Quality of Life Assessment

    Time frame: 90-days post-procedure

    The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

  18. FDA Clearance Cohort: Rate of All-Cause Mortality

    Time frame: 90-days post-procedure

    Rate of 90-day all-cause mortality

  19. FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)

    Time frame: 24-hour post-procedure

    Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

  20. FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)

    Time frame: End of procedure to 24-hour post-procedure

    Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

  21. FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)

    Time frame: 90-days post-procedure

    Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

  22. FDA Clearance Cohort: Rate of Serious Adverse Events

    Time frame: 90-days post-procedure

    All serious adverse events through 90 days post-procedure.

  23. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b

    Time frame: Intraprocedural

    The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b flow.

    mTICI range: 0 to 3; higher score means better reperfusion

  24. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better reperfusion

  25. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success

    Time frame: Intraprocedural

    Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

    mTICI range: 0 to 3; higher score means better reperfusion

  26. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion

    Time frame: Intraprocedural

    Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

    mTICI range: 0 to 3; higher score means better reperfusion

  27. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence

    Time frame: 90-days post-procedure

    The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

    The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

  28. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment

    Time frame: 90-days post-procedure

    The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

  29. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality

    Time frame: 90-days post-procedure

    Rate of 90-day all-cause mortality

  30. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)

    Time frame: 24-hour post-procedure

    Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

  31. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)

    Time frame: End of procedure to 24-hour post-procedure

    Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

  32. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)

    Time frame: 90-days post-procedure

    Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

  33. FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events

    Time frame: 90-days post-procedure

    All serious adverse events through 90 days post-procedure

Sponsors and collaborators

Lead sponsor

Imperative Care, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2019
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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