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.
Brief Title
The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ischemic Stroke
Acute Stroke
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Keywords
stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04129125
Org Class
Industry
Org Full Name
Imperative Care, Inc.
Org Study Id
ICI-001
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Primary Efficacy Endpoint
Outcome Time Frame
Intraprocedural
Outcome Description
Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging
Outcome Measure
Primary Safety Endpoint
Outcome Time Frame
24-hour post-procedure
Secondary Outcomes
Outcome Description
The time from groin puncture to mTICI score ≥ 2b flow
Outcome Time Frame
Intraprocedural
Outcome Measure
Time to achieve mTICI score ≥ 2b
Outcome Description
The proportion of patients achieving mTICI score 3 flow
Outcome Time Frame
Intraprocedural
Outcome Measure
Rate of mTICI score 3 reperfusion
Outcome Description
The proportion of patients where the mTICI score ≥ 2b reperfusion was accomplished with the first pass
Outcome Time Frame
Intraprocedural
Outcome Measure
First pass success
Outcome Description
The proportion of patients achieving mTICI score ≥ 2c flow
Outcome Time Frame
Intraprocedural
Outcome Measure
Rate of mTICI score 2c reperfusion
Outcome Description
The proportion of patients achieving Modified Rankin Scale (mRS) ≤2 using the primary treatment modality
Outcome Time Frame
90 days post-procedure
Outcome Measure
Functional Independence
Outcome Description
Measured by Stroke Impact Scale (SIS) Questionnaire
Outcome Time Frame
90 days post-procedure
Outcome Measure
Quality of Life Assessment
Outcome Description
All-cause mortality
Outcome Time Frame
90 days post-procedure
Outcome Measure
Mortality
Outcome Description
All ICH, as confirmed by imaging
Outcome Time Frame
24-hour post-procedure
Outcome Measure
Intracranial hemorrhage (ICH)
Outcome Description
Emboli observed immediately after thrombectomy and in a previously unaffected territory
Outcome Time Frame
Intraprocedural
Outcome Measure
Embolization in new territory (ENT)
Outcome Description
All SADEs
Outcome Time Frame
90 days post-procedure
Outcome Measure
Serious adverse device effects (SADEs)
Outcome Description
All serious adverse events
Outcome Time Frame
90 days post-procedure
Outcome Measure
Serious adverse events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Neil Haranhalli
Investigator Email
nharanha@montefiore.org
Investigator Phone
NHARANHA