A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke

NCT04437862 | Completed DMC FDA Device

• 1 other identifier: 101773
• Study Type: interventional
• Target: 121
• Locations: 2 countries
• Sites: 8

Brief Summary

Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli from the neurovasculature in patients experiencing an acute ischemic stroke

Conditions

Acute Stroke; Cerebral Ischemia

Outcome Measures

Primary Outcomes (2)

• Successful revascularization rate

  Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure

  Procedure end

• Symptomatic intracranial haemorrhage rate

  Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4

  36 hours post procedure

Secondary Outcomes (8)

• Successful revascularization rate with study device

  Procedure

• Successful revascularization rate on the first attempt with study device

  Procedure

• Procedure Time

  Procedure

• ENT rate

  Procedure

• Procedure Complications

  Procedure through 90 days

Study Arms (1)

Q Revascularization System

EXPERIMENTAL

Device: Q Revascularization System

Interventions

Q Revascularization System DEVICE

Q Revascularization System for mechanical thrombectomy

Q Revascularization System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Pre-stroke independent functional status in activities of daily living with mRS 0-1.
• A disabling stroke defined as NIHSS ≥ 6
• In USA thrombolytic therapy (IV tPA) received within 3 hours of onset/ last known well, in Europe treatment with IV tPA received within 4.5 hours from onset/ last known well OR ineligibility for thrombolytic therapy
• Endovascular treatment intended to be initiated \< 8 hours from onset of symptoms or last known well time
• Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, M2, basilar or intracerebral vertebral artery by baseline neuroimaging CTA/MRA and angiographic imaging with a mTICI Score 0-1
• For strokes in the anterior circulation the following imaging criteria should also be met: MRI criterion of volume of diffusion restriction visually assessed ≤50 mL OR CT criterion of ASPECTS 6 to 10 on baseline CT or CTA-source images or, significantly lowered cerebral blood volume (CBV) ≤50 mL
• For strokes in the basilar or vertebral artery, the following imaging criterion should also be met: pc-ASPECTS score 8 to 10 on baseline CT, CTA-source images, or MRI
• Signed informed consent from subject, acceptable person responsible (e.g. LAR) and/or according to County specific regulatory requirements and local ethical committee or review board requirements

You may not qualify if:

• CT or MRI evidence of intracranial hemorrhage on presentation
• CT or MRI showing mass effect or intracranial tumor (meningioma \> 2 cm in diameter).
• Previous stroke within the past 3 months
• Rapidly improving neurological status as determined by Investigator/Neurologist
• Renal failure/insufficiency with \>3.0 mg/dL creatinine prior to procedure
• Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP \>110 mmHg)
• Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency
• For patients who have received a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure
• Platelet count \< 50,000 mm3
• Cerebral vasculitis or evidence of active systemic infection
• Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis
• Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
• Seizure due to stroke
• Pregnancy
• Severe contrast allergy or absolute contraindication to iodinated contrast

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

Study Sites (8)

University of South Florida

Tampa, Florida, 33620, United States

Location

Cooper University Health Care

Camden, New Jersey, 08103, United States

Location

University at Buffalo Neurosurgery

Buffalo, New York, 14208, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

CHU Pellegrin

Bordeaux, 33000, France

Location

CHU Urbains

Nancy, 54035, France

Location

CHU Bicetre Paris

Paris, 94270, France

Location

Hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Stroke; Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Cognard, PhD, MD

  Hôpital Purpan

  PRINCIPAL INVESTIGATOR

• Lucas Elijovich, MD

  University of Tennessee Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Brian Jankowitz, MD

  JFK University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: October 27, 2020
• Primary Completion: April 21, 2023
• Study Completion: August 2, 2023
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); US (4)