Clinical trial NCT04129125: The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Acute Stroke
Keywords: stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
Lead sponsor: Imperative Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, open-label with independent outcome assessments.
Primary purpose: TREATMENT

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.

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

    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

Primary outcomes:
measure: Primary Efficacy Endpoint
timeFrame: Intraprocedural
measure: Primary Safety Endpoint
timeFrame: 24-hour post-procedure
Secondary outcomes:
measure: Time to achieve mTICI score ≥ 2b
timeFrame: Intraprocedural
measure: Rate of mTICI score 3 reperfusion
timeFrame: Intraprocedural
measure: First pass success
timeFrame: Intraprocedural
measure: Rate of mTICI score 2c reperfusion
timeFrame: Intraprocedural
measure: Functional Independence
timeFrame: 90 days post-procedure
measure: Quality of Life Assessment
timeFrame: 90 days post-procedure
measure: Mortality
timeFrame: 90 days post-procedure
measure: Intracranial hemorrhage (ICH)
timeFrame: 24-hour post-procedure
measure: Embolization in new territory (ENT)
timeFrame: Intraprocedural
measure: Serious adverse device effects (SADEs)
timeFrame: 90 days post-procedure
measure: Serious adverse events
timeFrame: 90 days post-procedure
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Radiology of Huntsville
state: Alabama
city: Tucson
country: United States
facility: Carondelet Neurological Institute St. Joseph's Hospital
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Walnut Creek
country: United States
facility: John Muir Health
state: California
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Miami
country: United States
facility: University of Miami / Jackson Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital / University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital / Emory University
state: Georgia
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Camden
country: United States
facility: Cooper University Health Care
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: The State University of New York at Buffalo
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health - Upstate
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System: Tennessee Interventional and Imaging Associates
state: Tennessee
city: Memphis
country: United States
facility: Semmes Murphey Foundation / Methodist University Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Harlingen
country: United States
facility: Valley Baptist Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston // Memorial Hermann Health System
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Pittsburgh
name: Raul G Nogueira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Reade A De Leacy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: William J Mack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperative Care, Inc.
name: Emir Deljkich
role: STUDY_DIRECTOR
References: