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Acute StrokeEvaQNCT04437862

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

A study testing Q Revascularization System in people with Acute Stroke and Cerebral Ischemia, run by MIVI Neuroscience, Inc. at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Stroke, Cerebral Ischemia
What is being tested?
Q Revascularization System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
8 sitesin 2 countries
Study dates
27 Oct 2020to 2 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

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 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
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  • 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

Who cannot join

  • 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)
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  • 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 locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United States4 sites

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14208

  • Cooper University Health Care

    Camden, New Jersey, 08103

  • Baptist Memorial Hospital

    Memphis, Tennessee, 38120

  • University of South Florida

    Tampa, Florida, 33620

Other trials in United States

France4 sites

  • CHU Pellegrin

    Bordeaux, 33000

  • CHU Urbains

    Nancy, 54035

  • CHU Bicetre Paris

    Paris, 94270

  • Hôpital Purpan

    Toulouse, 31059

Other trials in France

About this study

Official title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study

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

Being tested
Q Revascularization System
Medical subject headings
Stroke, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q Revascularization SystemDevice

    Q Revascularization System for mechanical thrombectomy

Study groups in NCT04437862
Study groupRoleWhat they receive
Q Revascularization SystemExperimentalNot described
Receives: Device: Q Revascularization System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful revascularization rate

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

    Measured: Procedure end

  2. Symptomatic intracranial haemorrhage rate

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

    Measured: 36 hours post procedure

Secondary outcomes (8)

  1. Successful revascularization rate with study device

    Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device

    Measured: Procedure

  2. Successful revascularization rate on the first attempt with study device

    Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device

    Measured: Procedure

  3. Procedure Time

    Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow

    Measured: Procedure

  4. ENT rate

    Embolization to a new vascular territory (ENT) during procedure

    Measured: Procedure

  5. Procedure Complications

    Rate of procedure related complications

    Measured: Procedure through 90 days

  6. ICH

    Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.

    Measured: 36 hours post procedure

  7. Good functional outcome

    Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2

    Measured: 90 days post procedure

  8. Mortality

    All cause mortality

    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.

  1. First posted18 Jun 2020
  2. Study start27 Oct 2020
  3. Primary completion21 Apr 2023
  4. Study completion2 Aug 2023

Resources

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
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437862
Sponsor's protocol ID
101773
Acronym
EvaQ
Status last verified
Aug 2024
First submitted
16 Jun 2020
Last updated
9 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Q Revascularization System in people with Acute Stroke and Cerebral Ischemia, run by MIVI Neuroscience, Inc. at 8 sites in 2 countries.

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 22 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Successful revascularization rate (time frame: Procedure end). The study lists 2 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 NCT04437862.

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 9 Aug 2024.

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