COlombia DAISe FEasibility Exercise (COFEE)

MIVI Neuroscience

Status

Terminated

Conditions

Stroke, Acute Ischemic

Treatments

Device: DAISe

Study type

Interventional

Funder types

Industry

Identifiers

NCT05631483

101929

Details and patient eligibility

About

This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 0-2.
Diagnosis of acute ischemic stroke with study enrollment time < 8 hours from onset of symptoms.
Disabling stroke defined as a baseline NIHSS > 6.
Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1.
Signed informed consent from patient or legal representative.

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.
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.
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 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).
A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.