DAISe 1 Feasibility Study to Evaluate the DAISe Thrombectomy System for Acute Ischemic Stroke

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: DAISe Thrombectomy System

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Cronin; Phone Number: 5184289593; Email: hcronin@mivineuro.com

Study Locations

• France
  • Bordeaux, France, 33000
    • CHU Pellegrin
  • Montpellier, France
    • CHU Montpellier
  • Nancy, France, 54035
    • CHU Urbains
  • Paris, France
    • Groupe Hospitalier Pitie-Salpetriere
  • Paris, France, 94270
    • CHU Bicetre Paris
  • Toulouse, France, 31059
    • Hôpital Purpan

Participation Criteria

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 (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1. 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 > 6.
• 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 0-1.
• 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.
• 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.
• Difficult endovascular access, 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.
• Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
• 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 cannot undergo an MRI of the head due to MRI contraindication.
• Patient is unable or unwilling complete follow up visits.
• If before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAISe Thrombectomy System; Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.	Device: DAISe Thrombectomy System; DAISe Thrombectomy System for mechanical thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of first pass revascularization success	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.	procedure
Rate of symptomatic intracranial hemorrhage	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	12-36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of successful revascularization with the DAISe Device	Successful revascularization of mTICI 2c-3 as a result of the first attempt with the DAISe Thrombectomy Device	Procedure
Rate of procedural final successful revascularization	Successful revascularization of final mTICI 2b-3 at the end of the procedure	Procedure
Rate of successful revascularization at procedure end	Successful revascularization of final mTICI 2c-3 at the end of the procedure	Procedure
Rate of successful device use	Measured by the successful delivery and placement of the DAISe Device in the target artery	Procedure
Procedure time	Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow	Procedure
Complications	Rate of procedure and/or device related complications	Procedure
Rate of ENT	Rate of embolization to a new vascular territory (ENT) during procedure	Procedure
Infarct volume	Infarct volume in MRI (FLAIR/Diffusion Weighted Imaging [DWI] combined)	12-36 hours
Emboli	Number of emboli outside of main infarct affected territory and outside the affected territory in high-resolution DWI	12-36 hours
Intracranial hemorrhage	Occurrence of all intracranial hemorrhage using the Heidelberg Bleeding Classification	12-36 hours
Good functional outcome	Good functional outcome measured by Modified Rankin Score (measured 0 completely functional to 6 deceased) of 0-2	3 months
Mortality Rate	All cause mortality	3 months

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.
• Investigators: Principal Investigator: Christophe Cognard, MD, PhD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 101995

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: No