A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study

MIVI Neuroscience, Inc.6 sites in 1 country16 target enrollmentJanuary 12, 2022

ConditionsAcute Ischemic Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Ischemic Stroke
Sponsor: MIVI Neuroscience, Inc.
Enrollment: 16
Locations: 6
Primary Endpoint: Rate of symptomatic intracranial hemorrhage
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.

Registry

clinicaltrials.gov

Start Date

January 12, 2022

End Date

August 4, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MIVI Neuroscience, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or older.
•Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-
•Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
•Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms.
•Disabling stroke defined as a baseline NIHSS \>
•Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy.
•Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-
•The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available
•Signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent.
•Patient is affiliated in the social security system.

Exclusion Criteria

•Computed tomography (CT) or Magnetic Resonance Imaging (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; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
•Severe contrast allergy or absolute contraindication to iodinated contrast.
•Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
•Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP \>110 mmHg).
•Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) with International Normalized Ratio (INR) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
•Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure.
•Cerebral vasculitis or evidence of active systemic infection.

Outcomes

Primary Outcomes

Rate of symptomatic intracranial hemorrhage

Time Frame: 12-36 hours

Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4

Rate of first pass revascularization success

Time Frame: procedure

First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration.