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

September 11, 2023 updated by: MIVI Neuroscience, Inc.

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

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bordeaux, France, 33000
        • Chu Pellegrin
      • Nancy, France, 54035
        • CHU Urbains
      • Paris, France, 94270
        • CHU Bicetre Paris
      • Toulouse, France, 31059
        • Hopital Purpan
    • Florida
      • Tampa, Florida, United States, 33620
        • University of South Florida
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Health Care
    • New York
      • Buffalo, New York, United States, 14208
        • University at Buffalo Neurosurgery
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Baptist Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Q Revascularization System
Q Revascularization System for mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful revascularization rate
Time Frame: Procedure end
Successful revascularization defined at modified Treatment in Cerebral Ischemia (mTICI) 2b-3 at the end of the procedure
Procedure end
Symptomatic intracranial haemorrhage rate
Time Frame: 36 hours post procedure
Symptomatic intracranial haemorrhage (ICH) as detected by CT/MRI and a clinical deterioration of NIHSS change ≥ 4
36 hours post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful revascularization rate with study device
Time Frame: Procedure
Successful revascularization defined as mTICI 2b-3 flow after all aspiration attempts with the study device
Procedure
Successful revascularization rate on the first attempt with study device
Time Frame: Procedure
Successful revascularization defined as mTICI 2b-3 flow after the first aspiration attempt with the study device
Procedure
Procedure Time
Time Frame: Procedure
Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow
Procedure
ENT rate
Time Frame: Procedure
Embolization to a new vascular territory (ENT) during procedure
Procedure
Procedure Complications
Time Frame: Procedure through 90 days
Rate of procedure related complications
Procedure through 90 days
ICH
Time Frame: 36 hours post procedure
Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.
36 hours post procedure
Good functional outcome
Time Frame: 90 days post procedure
Good functional outcome measured by Modified Rankin Score (mRS) defined as a value of 0-2
90 days post procedure
Mortality
Time Frame: 90 days post procedure
All cause mortality
90 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher Cognard, PhD, MD, Hopital Purpan
  • Principal Investigator: Lucas Elijovich, MD, University of Tennessee Health Sciences Center
  • Principal Investigator: Brian Jankowitz, MD, School of Medicine at the University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2020

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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