Ischemic StrokeNCT04129125
The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
A study testing Zoom Reperfusion System in people with Ischemic Stroke and Acute Stroke, run by Imperative Care, Inc. at 28 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute Stroke
- What is being tested?
- Zoom Reperfusion System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 28 sitesUnited States
- Study dates
- 1 Oct 2021to 28 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- 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
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United States28 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Grady Memorial Hospital / Emory University
Atlanta, Georgia, 30303
The State University of New York at Buffalo
Buffalo, New York, 14203
Cooper University Health Care
Camden, New Jersey, 08103
Erlanger Health System: Tennessee Interventional and Imaging Associates
Chattanooga, Tennessee, 37403
The Ohio State University Medical Center
Columbus, Ohio, 43235
Baylor Scott and White Research Institute
Dallas, Texas, 75204
Spectrum Health
Grand Rapids, Michigan, 49503
Prisma Health - Upstate
Greenville, South Carolina, 29615
Valley Baptist Medical Center
Harlingen, Texas, 78550
The University of Texas Health Science Center at Houston // Memorial Hermann Health System
Houston, Texas, 77007
Radiology of Huntsville
Huntsville, Alabama, 35801
Baptist Health
Jacksonville, Florida, 32207
University of Southern California
Los Angeles, California, 90033
Semmes Murphey Foundation / Methodist University Hospital
Memphis, Tennessee, 38120
University of Miami / Jackson Memorial Hospital
Miami, Florida, 33136
Ochsner Health
New Orleans, Louisiana, 70121
Mount Sinai
New York, New York, 10029
Oklahoma University
Oklahoma City, Oklahoma, 73104
UPMC
Pittsburgh, Pennsylvania, 15213
University of Pennsylvania
Pittsburgh, Pennsylvania, 19104
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Tallahassee Neurological Clinic
Tallahassee, Florida, 32308
Tampa General Hospital / University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Munson Medical Center
Traverse City, Michigan, 49684
Carondelet Neurological Institute St. Joseph's Hospital
Tucson, Arizona, 85711
John Muir Health
Walnut Creek, California, 94598
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute Stroke
- Being tested
- Zoom Reperfusion System
- Keywords
- stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoom Reperfusion SystemDevice
Thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Zoom Reperfusion System | Experimental | 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. Receives: Device: Zoom Reperfusion System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Measured: Intraprocedural
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Measured: 24-hour post-procedure
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Measured: Intraprocedural
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Measured: 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
Measured: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Measured: 24-hour post-procedure
Secondary outcomes (33)
ITT Cohort: Time to Achieve mTICI Score ≥ 2b
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
ITT Cohort: Rate of mTICI Score 3 Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
ITT Cohort: Rate of First Pass Success
Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device
mTICI range: 0 to 3; higher score means better outcome
Measured: Intraprocedural
ITT Cohort: Rate of mTICI Score 2c Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better outcome
Measured: Intraprocedural
ITT Cohort: Rate of Functional Independence
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death
Measured: 90-days post-procedure
ITT Cohort: Quality of Life Assessment
The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.
Measured: 90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Measured: 90 days post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Measured: 24-hour post-procedure
ITT Cohort: Rate of Embolization in New Territory (ENT)
Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke
Measured: 24-hour post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Measured: 90 days post-procedure
ITT Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Measured: 90 days post-procedure
FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better outcome
Measured: Intraprocedural
FDA Clearance Cohort: Rate of First Pass Success
Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device
mTICI range: 0 to 3; higher score means better outcome
Measured: Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort: Rate of Functional Independence
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Measured: 90-days post-procedure
FDA Clearance Cohort: Quality of Life Assessment
The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.
Measured: 90-days post-procedure
FDA Clearance Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Measured: 90-days post-procedure
FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Measured: 24-hour post-procedure
FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)
Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke
Measured: End of procedure to 24-hour post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Measured: 90-days post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Measured: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b flow.
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success
Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion
Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)
mTICI range: 0 to 3; higher score means better reperfusion
Measured: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence
The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors
The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.
Measured: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment
The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.
Measured: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Measured: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Measured: 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)
Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke
Measured: End of procedure to 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Measured: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure
Measured: 90-days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Oct 2021
- Primary completion28 May 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicenter, open-label with independent outcome assessments.
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperative Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raul G Nogueira, MD, Principal investigator, University of PittsburghReade A De Leacy, MD, Principal investigator, Icahn School of Medicine at Mount SinaiWilliam J Mack, MD, Principal investigator, University of Southern CaliforniaEmir Deljkich, Study director, Imperative Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129125
- Sponsor's protocol ID
- ICI-001
- Status last verified
- Aug 2025
- First submitted
- 27 Sep 2019
- Last updated
- 8 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Mack W, De Leacy RA, Grossberg JA, Majidi S, Tomalty RD, Mokin M, Vargas J, Cucchiara BL, Snyder KV, Mascitelli J, Parada V, Shakir HJ, Rosenbaum-Halevi D, Aghaebrahim A, Hoit D, Yim B, Tenser MS, Al-Bayati AR, Milburn JM, Nimjee SM, Haranhalli N, Nahhas M, Shaff D, Layton KF, Beaty N, Starke RM, Hawk H, Haussen DC, Pabaney A, Kellner CP, Nogueira RG. Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial. J Neurointerv Surg. 2026 Apr 16;18(5):1202-1209. doi: 10.1136/jnis-2025-023719.
PubMed 40695608
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129125
- Acronym / sponsor ID
- ICI-001
- Conditions
- Ischemic Stroke, Acute Stroke
- Keywords
- stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Imperative Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 May 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 8 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicenter, open-label with independent outcome assessments.
| Arm | Type | Receives |
|---|---|---|
| Zoom Reperfusion System | Experimental | Device: Zoom Reperfusion SystemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoom Reperfusion SystemThrombectomy | Device | Zoom Reperfusion System |
Primary outcome
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Time frame: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Time frame: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Time frame: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Time frame: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
Time frame: Intraprocedural
Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Time frame: 24-hour post-procedure
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
33 secondary outcomes
ITT Cohort: Time to Achieve mTICI Score ≥ 2b
Time frame: Intraprocedural
ITT Cohort: Rate of mTICI Score 3 Reperfusion
Time frame: Intraprocedural
ITT Cohort: Rate of First Pass Success
Time frame: Intraprocedural
ITT Cohort: Rate of mTICI Score 2c Reperfusion
Time frame: Intraprocedural
ITT Cohort: Rate of Functional Independence
Time frame: 90-days post-procedure
ITT Cohort: Quality of Life Assessment
Time frame: 90 days post-procedure
ITT Cohort: Rate of All-Cause Mortality
Time frame: 90 days post-procedure
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Time frame: 24-hour post-procedure
ITT Cohort: Rate of Embolization in New Territory (ENT)
Time frame: 24-hour post-procedure
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Time frame: 90 days post-procedure
ITT Cohort: Rate of Serious Adverse Events
Time frame: 90 days post-procedure
FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b
Time frame: Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion
Time frame: Intraprocedural
FDA Clearance Cohort: Rate of First Pass Success
Time frame: Intraprocedural
FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion
Time frame: Intraprocedural
FDA Clearance Cohort: Rate of Functional Independence
Time frame: 90-days post-procedure
FDA Clearance Cohort: Quality of Life Assessment
Time frame: 90-days post-procedure
FDA Clearance Cohort: Rate of All-Cause Mortality
Time frame: 90-days post-procedure
FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)
Time frame: 24-hour post-procedure
FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)
Time frame: End of procedure to 24-hour post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)
Time frame: 90-days post-procedure
FDA Clearance Cohort: Rate of Serious Adverse Events
Time frame: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b
Time frame: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion
Time frame: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success
Time frame: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion
Time frame: Intraprocedural
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence
Time frame: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment
Time frame: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality
Time frame: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)
Time frame: 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)
Time frame: End of procedure to 24-hour post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)
Time frame: 90-days post-procedure
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events
Time frame: 90-days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40695608Mack W, De Leacy RA, Grossberg JA, Majidi S, Tomalty RD, Mokin M, Vargas J, Cucchiara BL, Snyder KV, Mascitelli J, Parada V, Shakir HJ, Rosenbaum-Halevi D, Aghaebrahim A, Hoit D, Yim B, Tenser MS, Al-Bayati AR, Milburn JM, Nimjee SM, Haranhalli N, Nahhas M, Shaff D, Layton KF, Beaty N, Starke RM, Hawk H, Haussen DC, Pabaney A, Kellner CP, Nogueira RG. Stroke thrombectomy with a novel reperfusion system including a 0.088'' aspiration catheter: the Imperative Trial. J Neurointerv Surg. 2026 Apr 16;18(5):1202-1209. doi: 10.1136/jnis-2025-023719.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul G Nogueira, MD principal investigator
University of Pittsburgh
Reade A De Leacy, MD principal investigator
Icahn School of Medicine at Mount Sinai
William J Mack, MD principal investigator
University of Southern California
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoom Reperfusion System in people with Ischemic Stroke and Acute Stroke, run by Imperative Care, Inc. at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success (time frame: Intraprocedural). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04129125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.