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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Acute Stroke
• Intervention / Treatment: Device: Zoom Reperfusion System

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.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Radiology of Huntsville
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Carondelet Neurological Institute St. Joseph's Hospital
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Walnut Creek, California, United States, 94598
      • John Muir Health
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
    • Miami, Florida, United States, 33136
      • University of Miami / Jackson Memorial Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital / University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Grady Memorial Hospital / Emory University
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Health Care
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Buffalo, New York, United States, 14203
      • The State University of New York at Buffalo
    • New York, New York, United States, 10029
      • Mount Sinai
  • Ohio
    • Columbus, Ohio, United States, 43235
      • The Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma University
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
    • Pittsburgh, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health - Upstate
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System: Tennessee Interventional and Imaging Associates
    • Memphis, Tennessee, United States, 38120
      • Semmes Murphey Foundation / Methodist University Hospital
  • Texas
    • Dallas, Texas, United States, 75204
      • Baylor Scott and White Research Institute
    • Harlingen, Texas, United States, 78550
      • Valley Baptist Medical Center
    • Houston, Texas, United States, 77007
      • The University of Texas Health Science Center at Houston // Memorial Hermann Health System
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success	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.	Intraprocedural
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board	24-hour post-procedure
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success	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.	Intraprocedural
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board	24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success	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.	Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board	24-hour post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ITT Cohort: Time to Achieve mTICI Score ≥ 2b	The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion	Intraprocedural
ITT Cohort: Rate of mTICI Score 3 Reperfusion	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	Intraprocedural
ITT Cohort: Rate of First Pass Success	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	Intraprocedural
ITT Cohort: Rate of mTICI Score 2c Reperfusion	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	Intraprocedural
ITT Cohort: Rate of Functional Independence	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	90-days post-procedure
ITT Cohort: Quality of Life Assessment	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.	90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality	Rate of 90-day all-cause mortality	90 days post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)	Independent core lab adjudicated rate of all ICH at 24-hour post-procedure	24-hour post-procedure
ITT Cohort: Rate of Embolization in New Territory (ENT)	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	24-hour post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)	Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure	90 days post-procedure
ITT Cohort: Rate of Serious Adverse Events	All serious adverse events through 90 days post-procedure.	90 days post-procedure
FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b	The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion	Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion	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	Intraprocedural
FDA Clearance Cohort: Rate of First Pass Success	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	Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion	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	Intraprocedural
FDA Clearance Cohort: Rate of Functional Independence	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.	90-days post-procedure
FDA Clearance Cohort: Quality of Life Assessment	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.	90-days post-procedure
FDA Clearance Cohort: Rate of All-Cause Mortality	Rate of 90-day all-cause mortality	90-days post-procedure
FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)	Independent core lab adjudicated rate of all ICH at 24-hour post-procedure	24-hour post-procedure
FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)	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	End of procedure to 24-hour post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)	Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure	90-days post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Events	All serious adverse events through 90 days post-procedure.	90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b	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	Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion	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	Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success	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	Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion	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	Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence	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.	90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment	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.	90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality	Rate of 90-day all-cause mortality	90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)	Independent core lab adjudicated rate of all ICH at 24-hour post-procedure	24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)	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	End of procedure to 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)	Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure	90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events	All serious adverse events through 90 days post-procedure	90-days post-procedure

Collaborators and Investigators

• Sponsor: Imperative Care, Inc.
• Investigators: Principal Investigator: Raul G Nogueira, MD, University of Pittsburgh; 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): May 28, 2024
• Study Completion (Actual): May 28, 2024

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: ICI-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes