Clinical trial NCT05139147: DAISe 1 Feasibility Study to Evaluate the DAISe Thrombectomy System for Acute Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Lead sponsor: MIVI Neuroscience, Inc.
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 0-1. 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.

Primary outcomes:
measure: Rate of first pass revascularization success
timeFrame: procedure
measure: Rate of symptomatic intracranial hemorrhage
timeFrame: 12-36 hours
Secondary outcomes:
measure: Rate of successful revascularization with the DAISe Device
timeFrame: Procedure
measure: Rate of procedural final successful revascularization
timeFrame: Procedure
measure: Rate of successful revascularization at procedure end
timeFrame: Procedure
measure: Rate of successful device use
timeFrame: Procedure
measure: Procedure time
timeFrame: Procedure
measure: Complications
timeFrame: Procedure
measure: Rate of ENT
timeFrame: Procedure
measure: Infarct volume
timeFrame: 12-36 hours
measure: Emboli
timeFrame: 12-36 hours
measure: Intracranial hemorrhage
timeFrame: 12-36 hours
measure: Good functional outcome
timeFrame: 3 months
measure: Mortality Rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Urbains
city: Paris
country: France
facility: CHU Bicetre Paris
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Toulouse
country: France
facility: Hôpital Purpan
Study officials:
affiliation: CHU Toulouse
name: Christophe Cognard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: