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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05139147
• Other study ID #: 101995
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: MIVI Neuroscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• DAISe Thrombectomy System
DAISe Thrombectomy System for mechanical thrombectomy

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux
France	CHU Montpellier	Montpellier
France	CHU Urbains	Nancy
France	CHU Bicetre Paris	Paris
France	Groupe Hospitalier Pitie-Salpetriere	Paris
France	Hôpital Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
MIVI Neuroscience, Inc.

Country where clinical trial is conducted

France, 

Outcome

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