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

M

MIVI Neuroscience

Status

Completed

Conditions

Cerebral Ischemia
Acute Stroke

Treatments

Device: Q Revascularization System

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure
  • Difficult endovascular access or difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy
  • Evidence of dissection in the carotid or target artery for treatment
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic
  • Active participation in another study involving an investigational drug or device
  • A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient
  • Unwillingness to complete follow up visits

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

121 participants in 1 patient group

Q Revascularization System
Experimental group
Treatment:
Device: Q Revascularization System

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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