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

NCT04129125 | Completed Results FDA Device

• 1 other identifier: ICI-001
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 28

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.

Conditions

Ischemic Stroke; Acute Stroke

Keywords

stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (33)

• ITT Cohort: Time to Achieve mTICI Score ≥ 2b

  Intraprocedural

• ITT Cohort: Rate of mTICI Score 3 Reperfusion

  Intraprocedural

• ITT Cohort: Rate of First Pass Success

  Intraprocedural

• ITT Cohort: Rate of mTICI Score 2c Reperfusion

  Intraprocedural

• ITT Cohort: Rate of Functional Independence

  90-days post-procedure

Study Arms (1)

Zoom Reperfusion System

EXPERIMENTAL

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

Interventions

Zoom Reperfusion System DEVICE

Thrombectomy

Zoom Reperfusion System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Imperative Care, Inc.: lead

Study Sites (28)

Radiology of Huntsville

Huntsville, Alabama, 35801, United States

Location

Carondelet Neurological Institute St. Joseph's Hospital

Tucson, Arizona, 85711, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

John Muir Health

Walnut Creek, California, 94598, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Miami / Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Tallahassee Neurological Clinic

Tallahassee, Florida, 32308, United States

Location

Tampa General Hospital / University of South Florida

Tampa, Florida, 33606, United States

Location

Grady Memorial Hospital / Emory University

Atlanta, Georgia, 30303, United States

Location

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

The State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43235, United States

Location

Oklahoma University

Oklahoma City, Oklahoma, 73104, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pennsylvania

Pittsburgh, Pennsylvania, 19104, United States

Location

Prisma Health - Upstate

Greenville, South Carolina, 29615, United States

Location

Erlanger Health System: Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, 37403, United States

Location

Semmes Murphey Foundation / Methodist University Hospital

Memphis, Tennessee, 38120, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75204, United States

Location

Valley Baptist Medical Center

Harlingen, Texas, 78550, United States

Location

The University of Texas Health Science Center at Houston // Memorial Hermann Health System

Houston, Texas, 77007, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Mack W, De Leacy RA, Grossberg JA, Majidi S, Tomalty RD, Mokin M, Vargas J, Cucchiara BL, Snyder KV, Mascitelli J, Parada V, Shakir HJ, Rosenbaum-Halevi D, Aghaebrahim A, Hoit D, Yim B, Tenser MS, Al-Bayati AR, Milburn JM, Nimjee SM, Haranhalli N, Nahhas M, Shaff D, Layton KF, Beaty N, Starke RM, Hawk H, Haussen DC, Pabaney A, Kellner CP, Nogueira RG. Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial. J Neurointerv Surg. 2025 Jul 22:jnis-2025-023719. doi: 10.1136/jnis-2025-023719. Online ahead of print.

  PMID: 40695608 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Didem Aksoy, Senior Director of Clinical Affairs
• Organization: Imperative Care

daksoy@imperativecare.com

650-644-8293

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Emir Deljkich

  Imperative Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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 24-hour NIHSS assessments are NIHSS certified team members not performing the thrombectomy procedure and with no financial conflict of interest with Imperative Care, Inc. 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, open-label with independent outcome assessments.

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 16, 2019
• Study Start: October 1, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: August 8, 2025
• Results First Posted: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (28)