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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04129125
• Other study ID #: ICI-001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Imperative Care, Inc.
• Contact: Pojai Phattanagosai
• Phone: 1.669.228.3908
• Email: pphattanagosai[@]imperativecare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: June 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Zoom Reperfusion System
Thrombectomy

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Grady Memorial Hospital / Emory University	Atlanta	Georgia
United States	Montefiore Medical Center	Bronx	New York
United States	The State University of New York at Buffalo	Buffalo	New York
United States	Cooper University Health Care	Camden	New Jersey
United States	Erlanger Health System: Tennessee Interventional and Imaging Associates	Chattanooga	Tennessee
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Baylor Scott and White Research Institute	Dallas	Texas
United States	Spectrum Health	Grand Rapids	Michigan
United States	Prisma Health - Upstate	Greenville	South Carolina
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	Radiology of Huntsville	Huntsville	Alabama
United States	Baptist Health	Jacksonville	Florida
United States	University of Southern California	Los Angeles	California
United States	Semmes Murphey Foundation / Methodist University Hospital	Memphis	Tennessee
United States	University of Miami / Jackson Memorial Hospital	Miami	Florida
United States	Ochsner Health	New Orleans	Louisiana
United States	Mount Sinai	New York	New York
United States	Oklahoma University	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Pittsburgh	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	Tampa General Hospital / University of South Florida	Tampa	Florida
United States	Munson Medical Center	Traverse City	Michigan
United States	Carondelet Neurological Institute St. Joseph's Hospital	Tucson	Arizona
United States	John Muir Health	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Imperative Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint	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.	Intraprocedural
Primary	Primary Safety Endpoint	Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging	24-hour post-procedure
Secondary	Time to achieve mTICI score = 2b	The time from groin puncture to mTICI score = 2b flow	Intraprocedural
Secondary	Rate of mTICI score 3 reperfusion	The proportion of patients achieving mTICI score 3 flow	Intraprocedural
Secondary	First pass success	The proportion of patients where the mTICI score = 2b reperfusion was accomplished with the first pass	Intraprocedural
Secondary	Rate of mTICI score 2c reperfusion	The proportion of patients achieving mTICI score = 2c flow	Intraprocedural
Secondary	Functional Independence	The proportion of patients achieving Modified Rankin Scale (mRS) =2 using the primary treatment modality	90 days post-procedure
Secondary	Quality of Life Assessment	Measured by Stroke Impact Scale (SIS) Questionnaire	90 days post-procedure
Secondary	Mortality	All-cause mortality	90 days post-procedure
Secondary	Intracranial hemorrhage (ICH)	All ICH, as confirmed by imaging	24-hour post-procedure
Secondary	Embolization in new territory (ENT)	Emboli observed immediately after thrombectomy and in a previously unaffected territory	Intraprocedural
Secondary	Serious adverse device effects (SADEs)	All SADEs	90 days post-procedure
Secondary	Serious adverse events	All serious adverse events	90 days post-procedure