COlombia DAISe FEasibility Exercise
Not Applicable
Terminated
- Conditions
- Stroke, Acute Ischemic
- Interventions
- Device: DAISe
- Registration Number
- NCT05631483
- Lead Sponsor
- MIVI Neuroscience, Inc.
- Brief Summary
This study is to assess initial safety and performance data of the DAISe Thrombectomy Device for removal of thrombus during an acute ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DAISe DAISe DAISe Thrombectomy Device
- Primary Outcome Measures
Name Time Method Rate of Successful Revascularization Procedure mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device
Rate of Symptomatic Intracranial Hemorrhage 24 hours post-procedure
- Secondary Outcome Measures
Name Time Method Rate of Procedure related Complications Through 90 day post-procedure Occurrence of all intracranial hemorrhage 24 hours post-procedure Successful Revascularization after first attempt with DAISe Procedure mTICI (modified TICI) 2c-3 after first pass with device
Successful Revascularization at end of procedure Procedure mTICI (modified TICI) 2c-3 at the end of procedure
All-cause mortality Through Acute Hospital Discharge Embolization to a New Vascular Territory Procedure
Trial Locations
- Locations (1)
Angiosur - Unidad Vascular Integral
🇨🇴ItagüÃ, Antioquia, Colombia