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

NCT ID: NCT04129125

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-05-28

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.

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.

Conditions

Ischemic Stroke; Acute Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Zoom Reperfusion System

Intervention Type: DEVICE

Thrombectomy

Interventions

Zoom Reperfusion System

Thrombectomy

Intervention Type: DEVICE

Eligibility 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 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperative Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raul G Nogueira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Reade A De Leacy, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

William J Mack, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Emir Deljkich

Role: STUDY_DIRECTOR

Imperative Care, Inc.

Locations

Radiology of Huntsville

Huntsville, Alabama, United States

Carondelet Neurological Institute St. Joseph's Hospital

Tucson, Arizona, United States

University of Southern California

Los Angeles, California, United States

John Muir Health

Walnut Creek, California, United States

Baptist Health

Jacksonville, Florida, United States

University of Miami / Jackson Memorial Hospital

Miami, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

Tampa General Hospital / University of South Florida

Tampa, Florida, United States

Grady Memorial Hospital / Emory University

Atlanta, Georgia, United States

Ochsner Health

New Orleans, Louisiana, United States

Spectrum Health

Grand Rapids, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Cooper University Health Care

Camden, New Jersey, United States

The State University of New York at Buffalo

Buffalo, New York, United States

Mount Sinai

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Oklahoma University

Oklahoma City, Oklahoma, United States

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

UPMC

Pittsburgh, Pennsylvania, United States

University of Pennsylvania

Pittsburgh, Pennsylvania, United States

Prisma Health - Upstate

Greenville, South Carolina, United States

Erlanger Health System: Tennessee Interventional and Imaging Associates

Chattanooga, Tennessee, United States

Semmes Murphey Foundation / Methodist University Hospital

Memphis, Tennessee, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

Valley Baptist Medical Center

Harlingen, Texas, United States

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

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40695608 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ICI-001

Identifier Type: -

Identifier Source: org_study_id