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

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ClinicalTrials.gov Identifier: NCT04129125
Recruitment Status : Recruiting
First Posted : October 16, 2019
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Imperative Care, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Acute Stroke Device: Zoom Reperfusion System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicenter, open-label with independent outcome assessments.
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 NIHSS assessments are dedicated, pre-specified trial team members with NIHSS certification but not involved in the patient's treatment.

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.

Primary Purpose: Treatment
Official 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
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.
Device: Zoom Reperfusion System
Thrombectomy




Primary Outcome Measures :
  1. Primary Efficacy Endpoint [ Time Frame: Intraprocedural ]
    Rate of reperfusion success, defined as achieving mTICI score ≥ 2b flow with the Zoom Reperfusion System (primary treatment modality) without using additional thrombectomy devices or rescue therapy.

  2. Primary Safety Endpoint [ Time Frame: 24-hour post-procedure ]
    Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging


Secondary Outcome Measures :
  1. Time to achieve mTICI score ≥ 2b [ Time Frame: Intraprocedural ]
    The time from groin puncture to mTICI score ≥ 2b flow

  2. Rate of mTICI score 3 reperfusion [ Time Frame: Intraprocedural ]
    The proportion of patients achieving mTICI score 3 flow

  3. First pass success [ Time Frame: Intraprocedural ]
    The proportion of patients where the mTICI score ≥ 2b reperfusion was accomplished with the first pass

  4. Rate of mTICI score 2c reperfusion [ Time Frame: Intraprocedural ]
    The proportion of patients achieving mTICI score ≥ 2c flow

  5. Functional Independence [ Time Frame: 90 days post-procedure ]
    The proportion of patients achieving Modified Rankin Scale (mRS) ≤2 using the primary treatment modality

  6. Quality of Life Assessment [ Time Frame: 90 days post-procedure ]
    Measured by Stroke Impact Scale (SIS) Questionnaire

  7. Mortality [ Time Frame: 90 days post-procedure ]
    All-cause mortality

  8. Intracranial hemorrhage (ICH) [ Time Frame: 24-hour post-procedure ]
    All ICH, as confirmed by imaging

  9. Embolization in new territory (ENT) [ Time Frame: Intraprocedural ]
    Emboli observed immediately after thrombectomy and in a previously unaffected territory

  10. Serious adverse device effects (SADEs) [ Time Frame: 90 days post-procedure ]
    All SADEs

  11. Serious adverse events [ Time Frame: 90 days post-procedure ]
    All serious adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129125


Contacts
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Contact: Pojai Phattanagosai 1.650.740.7703 pphattanagosai@imperativecare.com
Contact: Lilach Ofri 1.408.483.3994 lofri@imperativecare.com

Locations
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United States, Florida
Tampa General Hospital / University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Amy DeNardo       amydenardo@usf.edu   
Contact: Rachel Karlnoski       karlnosk@usf.edu   
Principal Investigator: Maxim Mokin, MD         
United States, Georgia
Grady Memorial Hospital / Emory University Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Shannon Doppelheuer       sdoppelheuer@emory.edu   
Principal Investigator: Alhamza Al-Bayati, MD         
United States, New York
Mount Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Sukaina Davdani       Sukaina.davdani@mountsinai.org   
Contact: Emily Fiano       Emily.fiano@mountsinai.org   
Principal Investigator: Shahram Majidi, MD         
United States, Ohio
The Ohio State University Medical Center Not yet recruiting
Columbus, Ohio, United States, 43235
Contact: Andrea Hesse       andrea.hesse@osumc.edu   
Contact: Amy Minnema       amy.minnema@osumc.edu   
Principal Investigator: Shahid Nimjee, MD, PhD         
United States, South Carolina
Prisma Health - Upstate Not yet recruiting
Greenville, South Carolina, United States, 29615
Principal Investigator: Jan Vargas, MD         
United States, Tennessee
Semmes Murphey Foundation / Methodist University Hospital Not yet recruiting
Memphis, Tennessee, United States, 38120
Contact: Jessica Ward       jfward@semmes-murphey.com   
Contact: Amanda Nolte       annolte@semmes-murphey.com   
Principal Investigator: Daniel Hoit, MD         
Sponsors and Collaborators
Imperative Care, Inc.
Investigators
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Principal Investigator: Raul G Nogueira, MD Grady Memorial Hospital
Principal Investigator: Reade A De Leacy, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: William J Mack, MD University of Southern California
Study Director: Emir Deljkich Imperative Care, Inc.
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Responsible Party: Imperative Care, Inc.
ClinicalTrials.gov Identifier: NCT04129125    
Other Study ID Numbers: ICI-001
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Imperative Care, Inc.:
stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis