COlombia DAISe FEasibility Exercise

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

Official Title
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A Feasibility Study for the DAISe Thrombectomy Device in Colombia

Conditions
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Stroke, Acute Ischemic

Intervention / Treatment
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* Device: DAISe


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAISe<br>DAISe Thrombectomy Device | Device: DAISe<br>* Use of the DAISe Thrombectomy Device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Successful Revascularization | mTICI (Modified TICI) 2b-3 of the target vessel post-treatment with the DAISe Thrombectomy Device | Procedure | 
| Rate of Symptomatic Intracranial Hemorrhage |  | 24 hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Procedure related Complications |  | Through 90 day post-procedure | 
| Occurrence of all intracranial hemorrhage |  | 24 hours post-procedure | 
| All-cause mortality |  | Through Acute Hospital Discharge | 
| Embolization to a New Vascular Territory |  | Procedure | 
| Successful Revascularization after first attempt with DAISe | mTICI (modified TICI) 2b-3 after first pass with device | Procedure | 
| Successful Revascularization after first attempt with DAISe | mTICI (modified TICI) 2c-3 after first pass with device | Procedure | 
| Successful Revascularization at end of procedure | mTICI (modified TICI) 2b-3 at the end of procedure | Procedure | 
| Successful Revascularization at end of procedure | mTICI (modified TICI) 2c-3 at the end of procedure | Procedure |