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A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03957278
Recruitment Status : Suspended (Device modifications)
First Posted : May 21, 2019
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
MIVI Neuroscience, Inc.

Brief Summary:
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.

Condition or disease Intervention/treatment Phase
Stroke, Acute Device: DAISe System Not Applicable

Detailed Description:
The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of >/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: DAISe System
The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.
Device: DAISe System
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.




Primary Outcome Measures :
  1. Number of participants with successful revascularization [ Time Frame: intra-procedural ]
    Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.

  2. Rate of symptomatic intracranial haemorrhage [ Time Frame: 12-36 hours post procedure ]
    24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4


Secondary Outcome Measures :
  1. Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
  2. Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
  3. Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure [ Time Frame: intra-procedural ]
  4. Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow [ Time Frame: intra-procedural ]
  5. Rate of procedure-related complications [ Time Frame: post procedure through discharge ]
  6. Rate of embolization to a new vascular territory (ENT) [ Time Frame: intra-procedural ]
  7. Good functional outcome for participants measured by Modified Rankin Scale score of 0-2. [ Time Frame: 30 days and 3 months post procedure ]
    The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).

  8. Quality of life for participants: PROMIS Scale [ Time Frame: 3 months post procedure ]
    PROMIS Scale

  9. Rate of all cause mortality [ Time Frame: 30 days and 3 months post procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 85 years.
  • Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
  • Disabling stroke defined as a baseline NIHSS > 6.
  • Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1.
  • If thrombolytic therapy (tPA) is administered, it must be administered per the prescribing information.
  • Confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs), or M2-MCA.
  • The following baseline imaging criteria should be met: MRI criterion: ASPECTS Score > 4 OR CT criterion: ASPECTS > 6
  • Signed informed consent from patient or legally authorized representative.

Exclusion Criteria:

  • CT or MRI evidence of recent/ fresh hemorrhage on presentation.
  • Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
  • Rapidly improving neurological deficits based on the investigator's clinical judgement.
  • Pregnancy
  • Severe contrast allergy or absolute contraindication to iodinated contrast.
  • No femoral pulses or very difficult endovascular access that will result in an inability to deliver endovascular therapy.
  • Evidence of dissection in the carotid or middle cerebral arteries.
  • Severe unilateral or bilateral carotid artery stenosis requiring treatment at the time of the procedure as determined during diagnostic angiography.
  • Renal failure (serum creatinine level ≥ 4 mg/dL or on dialysis).
  • Severe, sustained hypertension (SBP >185 mmHg or DBP >110 mmHg).
  • Cerebral vasculitis.
  • 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.
  • Platelet count < 50,000/mm3.
  • A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
  • Patient is unable or unwilling complete follow up visits.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957278


Locations
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Belgium
Erasme Hospital
Brussels, Belgium, 1070
Hospital Civil Marie Curie
Charleroi, Belgium, 140
Sponsors and Collaborators
MIVI Neuroscience, Inc.
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Responsible Party: MIVI Neuroscience, Inc.
ClinicalTrials.gov Identifier: NCT03957278    
Other Study ID Numbers: 101361
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MIVI Neuroscience, Inc.:
Mechanical thrombectomy
Acute ischemic stroke
neurovascular intervention
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases