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
Phase: NA
Conditions: Ischemic Stroke, Acute Stroke
Sponsor: Imperative Care, Inc.

Imperative Trial: 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 
 
NCT Number: NCT04129125 
Version Date: December 21, 2022 
Version: I 
 
 

Imperative Trial Protocol 
 
 
 
Imperative Care 
Confidential 
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Protocol Synopsis 
Trial Name 
Imperative Trial 
Sponsor 
Imperative Care, Inc. 
Trial Number 
ICI-001 
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  
Investigational or 
Trial Device 
The Zoom Reperfusion System uses single lumen catheters that have been 
specifically designed to track through the tortuous anatomy of the 
neurovasculature and are intended to be used, in conjunction with a vacuum 
source, to remove thrombus in order to restore blood flow to the brain during 
an acute ischemic stroke.  
 
The Zoom Reperfusion System includes the commercially available Imperative 
Care 0.088” ID Catheters and the Zoom Reperfusion Catheters (0.035” to 0.071” 
ID Catheters), Zoom Aspiration Tubing, and Zoom Aspiration Pump (or 
equivalent vacuum pump). The Imperative Care 0.088” ID Catheters have FDA 
clearance for facilitating introduction of interventional devices into the 
neurovasculature and the Zoom Reperfusion Catheters, with the Zoom 
Aspiration Tubing and Zoom Aspiration Pump (or equivalent aspiration pump), 
have FDA clearance for direct aspiration of thrombus from the 
neurovasculature. 
 
Within this trial, the Imperative Care 0.088” ID Catheters will be used as the 
primary access device for all cases and direct aspiration where feasible. If a Zoom 
Reperfusion Catheter is used for direct aspiration, the Imperative Care 0.088” ID 
Catheter should be positioned as close to the occlusion as possible and 
aspiration applied as the Zoom Reperfusion Catheter is retracted into the lumen 
of the Imperative Care 0.088” ID Catheter.      
Objectives 
To assess the safety and efficacy of the Zoom Reperfusion System in subjects 
diagnosed with 
acute 
ischemic 
stroke 
and 
undergoing mechanical 
thrombectomy procedure. 
Control Devices 
N/A - This is a single arm study. 

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Indications for Use 
The Zoom Reperfusion System, including the Zoom Aspiration Tubing and Zoom 
Aspiration Pump (or equivalent vacuum pump), are indicated for use in the 
revascularization of patients with acute ischemic stroke secondary to 
intracranial large vessel occlusive disease (within the internal carotid, middle 
cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours 
of symptom onset. 
 
Patients who are ineligible for intravenous thrombolytic therapy or who fail 
thrombolytic therapy are candidates for treatment. 
Clinical Trial/ 
Investigation Design 
Prospective, Multicenter, Open label, Single arm study to assess safety and 
reperfusion success following thrombectomy within 8 hours of stroke onset  
Subject Population 
Acute ischemic stroke patients eligible for mechanical thrombectomy within 8 
hours of symptom onset or time last seen normal and meeting all trial 
inclusion/exclusion criteria.  
Number of Subjects 
Up to 350 subjects will be enrolled to yield 262 evaluable subjects after 
excluding the post consent screen failures. Enrollment will stop when the 
target number of evaluable subjects or enrollment limit has been reached.  
Number of 
Arms/Randomization 
Single arm/No randomization 
Number of Centers 
Up to 30 sites (US) 

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Trial Endpoint(s) 
Primary Efficacy Endpoint: 
The primary efficacy endpoint is reperfusion success, defined as achieving a 
mTICI score ≥ 2b in three or less passes of the Zoom Reperfusion System (primary 
modality) without using additional thrombectomy devices or rescue therapy. 
Secondary Efficacy Endpoints: 
• 
Time to achieve mTICI score ≥ 2b, defined as the time from groin 
puncture to physician assessment of mTICI score ≥ 2b 
• 
The mTICI 3 success rate, defined as the proportion of patients achieving 
mTICI score  3 flow 
• 
First pass success rate (mTICI score ≥ 2b), defined as the proportion of 
patients where the primary treatment was accomplished with the first 
pass  
• 
The mTICI 2c success rate, defined as the proportion of patients 
achieving mTICI score ≥ 2c flow  
• 
Modified Rankin Scale (mRS) ≤2 at 90 days using the primary treatment 
modality 
• 
Quality of Life Assessement, measured by Stroke Impact Scale (SIS) 
Questionnaire.  
 
Primary Safety Endpoint: 
• 
Symptomatic intracranial hemorrhage (sICH), as confirmed by imaging, 
at the 24-hour post-procedure visit 
Secondary Safety Endpoints: 
• 
90-day all-cause mortality 
• 
Intracranial hemorrhage (ICH) as confirmed by imaging at the 24-hour 
post-procedure visit 
• 
Embolization in new territory (ENT) 
• 
All serious adverse device effects (SADEs) through 90 days post-
procedure 
• 
All serious adverse events through 90 days 
Follow-up 
Subjects will be followed for 90 days post-procedure, combining office visits and 
phone contact 

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ICI-001                                                                                                                              Version I, December 21, 2022 
 
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 

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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 
Determination of 
Sample Size 
The sample size for this trial was based on determining the number of subjects 
needed to demonstrate that the performance goals established for the primary 
safety and efficacy endpoints, as well as the first Secondary Safety endpoint, will 
be met with 90% probability of success or power.  
Sponsor 
Study Management 
Imperative Care, Inc. 
1359 Dell Avenue 
Campbell, CA 95008 
USA 
www.imperativecare.com 
 
Contact:  Emir Deljkich 
Title:  Vice President, Clinical Affairs 
Telephone:  +1-650-743-4346 
 
Email:  edeljkich@imperativecare.com