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

Sponsor
MIVI Neuroscience, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04437862
Collaborator
(none)
100
Enrollment
8
Locations
1
Arm
24.1
Anticipated Duration (Months)
12.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: Q Revascularization System
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study
Actual Study Start Date :
Oct 27, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Q Revascularization System

Device: Q Revascularization System
Q Revascularization System for mechanical thrombectomy

Outcome Measures

Primary Outcome Measures

  1. Successful revascularization rate [Procedure end]

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

  2. Symptomatic intracranial haemorrhage rate [36 hours post procedure]

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

Secondary Outcome Measures

  1. Successful revascularization rate with study device [Procedure]

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

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

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

  3. Procedure Time [Procedure]

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

  4. ENT rate [Procedure]

    Embolization to a new vascular territory (ENT) during procedure

  5. Procedure Complications [Procedure through 90 days]

    Rate of procedure related complications

  6. ICH [36 hours post procedure]

    Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification.

  7. Good functional outcome [90 days post procedure]

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

  8. Mortality [90 days post procedure]

    All cause mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Florida Tampa Florida United States 33620
2 Cooper University Health Care Camden New Jersey United States 08103
3 University at Buffalo Neurosurgery Buffalo New York United States 14208
4 Baptist Memorial Hospital Memphis Tennessee United States 38120
5 CHU Pellegrin Bordeaux France 33000
6 CHU Urbains Nancy France 54035
7 CHU Bicetre Paris Paris France 94270
8 Hôpital Purpan Toulouse France 31059

Sponsors and Collaborators

  • MIVI Neuroscience, Inc.

Investigators

  • Principal Investigator: Christopher Cognard, PhD, MD, Hôpital Purpan
  • Principal Investigator: Lucas Elijovich, MD, University of Tennessee Health Sciences Center
  • Principal Investigator: Brian Jankowitz, MD, Cooper University Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MIVI Neuroscience, Inc.
ClinicalTrials.gov Identifier:
NCT04437862
Other Study ID Numbers:
  • 101773
First Posted:
Jun 18, 2020
Last Update Posted:
Nov 11, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Stroke
Ischemic Stroke
Brain Ischemia
Cerebral Infarction
Ischemia

Study Results

No Results Posted as of Nov 11, 2021