Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients

MIVI Neuroscience

Status

Withdrawn

Conditions

Cerebrovascular Accident

Stroke

Stroke, Acute

Stroke, Ischemic

Cerebrovascular Disorders

Treatments

Device: Trevo or Solitaire

Device: DAISe Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04991038

101903

Details and patient eligibility

About

Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years and older
Pre-stroke independent functional status in activities of daily living with modified Rankin Score 0-1
Patient presenting with a disabling stroke device as NIHSS ≥6
Thrombolytic therapy (IV tPA), if indicated/administered, was initiated within 3 hours of onset/ last known well according to prescribed dosing.Endovascular treatment intended to be initiated (groin puncture) <24 hours from onset of symptoms or last known well time.
Confirmed symptomatic large vessel occlusion of the intracranial internal carotid artery, M1 or proximal M2 segment of the middle cerebral artery.
The following image criteria should also be met:

For Subjects 0-6hrs onset:

MRI Criterion: volume of diffusion restriction as assessed by automated core volume software ≤50mL OR
CT Criterion: ASPECTS 6-10 on baseline CT or CTA-source images or, CPT as assessed by automated core volume software ≤50mL

For subjects 6-24hrs onset:

≤20mL Ischemic core volume if age >80
≤30mL Ischemic core volume if age <80 and NIHSS 10-20
≤50mL Ischemic core volume if age <80 and NIHSS >20
Signed informed consent from patient or legal authorized representative.

Exclusion criteria

CT or MRI evidence of intracranial hemorrhage on presentation.
CT or MRI showing mass effect or intracranial tumor (meningioma >2cm in diameter)
CT or MRI evidence of carotid dissection or complete cervical carotid occlusion requiring a stent.
Previous stroke within the past 3 months.
Known arterial condition (proximal vessel stenosis or pre-existing stent) that would prevent the study devices from reaching the target vessel and/or preclude safe recovery of the study devices.
Pregnancy.
Severe contrast allergy or absolute contraindication to iodinated contrast.
Rapidly improving neurological status as determined by Investigator/Neurologist.
Renal failure/insufficiency with >3.0 mg/dL creatinine prior to procedure.
Severe, sustained hypertension resistant to treatment (SBP>185mmHg or DBP >110mmHg)
Use of warfarin anticoagulation with International Normalized Ratio (INR) >3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
For patients who have received a direct thrombin inhibitor within the last 48hrs; partial thromboplastin time (PTT) > 2.0 times the normal prior to procedure.
Platelet count < 50,000
Cerebral vasculitis or evidence of active systemic infection (including COVID-19)
Suspicion of aortic dissection, septic embolus, or 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.
Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
Active participation in another study involving an investigational drug or device.
A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
Unwillingness to complete follow up visits.