The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
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| ClinicalTrials.gov Identifier: NCT04129125 |
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Recruitment Status :
Recruiting
First Posted : October 16, 2019
Last Update Posted : March 22, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Stroke Acute Stroke | Device: Zoom Reperfusion System | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 262 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Prospective, multicenter, open-label with independent outcome assessments. |
| Masking: | None (Open Label) |
| Masking Description: | Reperfusion will be graded by an independent core lab that is not an enrolling investigational site. Neurological Outcome Assessors (NIHSS assessment): Neurological outcome assessors who will perform post-procedure 24-hour NIHSS assessments are NIHSS certified team members not performing the thrombectomy procedure and with no financial conflict of interest with Imperative Care, Inc. Functional Outcome Assessors (mRS assessment): Functional outcome assessors who will perform post-procedure assessments are part of achieving unbiased study objectives. They will not have access to patient data. |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | October 1, 2021 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | September 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Device: Zoom Reperfusion System
Thrombectomy |
- Primary Efficacy Endpoint [ Time Frame: Intraprocedural ]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.
- Primary Safety Endpoint [ Time Frame: 24-hour post-procedure ]Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging
- Time to achieve mTICI score ≥ 2b [ Time Frame: Intraprocedural ]The time from groin puncture to mTICI score ≥ 2b flow
- Rate of mTICI score 3 reperfusion [ Time Frame: Intraprocedural ]The proportion of patients achieving mTICI score 3 flow
- First pass success [ Time Frame: Intraprocedural ]The proportion of patients where the mTICI score ≥ 2b reperfusion was accomplished with the first pass
- Rate of mTICI score 2c reperfusion [ Time Frame: Intraprocedural ]The proportion of patients achieving mTICI score ≥ 2c flow
- Functional Independence [ Time Frame: 90 days post-procedure ]The proportion of patients achieving Modified Rankin Scale (mRS) ≤2 using the primary treatment modality
- Quality of Life Assessment [ Time Frame: 90 days post-procedure ]Measured by Stroke Impact Scale (SIS) Questionnaire
- Mortality [ Time Frame: 90 days post-procedure ]All-cause mortality
- Intracranial hemorrhage (ICH) [ Time Frame: 24-hour post-procedure ]All ICH, as confirmed by imaging
- Embolization in new territory (ENT) [ Time Frame: Intraprocedural ]Emboli observed immediately after thrombectomy and in a previously unaffected territory
- Serious adverse device effects (SADEs) [ Time Frame: 90 days post-procedure ]All SADEs
- Serious adverse events [ Time Frame: 90 days post-procedure ]All serious adverse events
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 18 and older
- NIHSS >=6
- 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
- Pre-event mRS scale 0-1
- 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
- For strokes in anterior circulation, ASPECTS >=6; For strokes in posterior circulation, pc-ASPECTS >=8
- 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
- If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible
- Consenting requirements met according to local IRB or Ethics Committee
Exclusion Criteria:
- Female known to be pregnant at time of admission
- Patient has suffered a stroke in the past 3 months
- Presence of an existing or pre-existing large territory infarction
- Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor
- Known history of severe contrast allergy or absolute contraindication to iodinated contrast
- Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
- Life expectancy of less than 6 months prior to stroke onset
- Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
- Subject participating in another clinical trial involving an investigational device or drug
- Known cancer with metastases
- Evidence of active systemic infection
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Any known hemorrhagic or coagulation deficiency
Imaging Exclusion Criteria:
- Evidence of intracranial hemorrhage on CT/MRI
- CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access
- Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088" ID Catheters
- Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices
- 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
- Significant mass effect with midline shift as confirmed on CT/MRI
- Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI
- Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129125
| Contact: Pojai Phattanagosai | 1.669.228.3908 | pphattanagosai@imperativecare.com | |
| Contact: Lilach Ofri | 1.408.483.3994 | lofri@imperativecare.com |
Show 23 study locations
| Principal Investigator: | Raul G Nogueira, MD | University of Pittsburgh | |
| Principal Investigator: | Reade A De Leacy, MD | Icahn School of Medicine at Mount Sinai | |
| Principal Investigator: | William J Mack, MD | University of Southern California | |
| Study Director: | Emir Deljkich | Imperative Care, Inc. |
| Responsible Party: | Imperative Care, Inc. |
| ClinicalTrials.gov Identifier: | NCT04129125 |
| Other Study ID Numbers: |
ICI-001 |
| First Posted: | October 16, 2019 Key Record Dates |
| Last Update Posted: | March 22, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
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stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS |
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Stroke Ischemic Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia Infarction Necrosis |