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

Study Overview
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Brief Summary
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Compare the safety and efficacy of the DAISE to stent retrievers in the treatment of acute ischemic stroke

Official Title
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Prospective, Multi-center, Randomized Study to Compare the Safety and Efficacy of the DAISe Thrombectomy System and Stent Retrievers for Neurointervention in Acute Ischemic Stroke

Conditions
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Stroke, Stroke, Ischemic, Stroke, Acute, Cerebrovascular Disorders, Cerebrovascular Accident

Intervention / Treatment
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* Device: DAISe Device
* Device: Trevo or Solitaire


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAISe Thrombectomy Device<br>Mechanical Thrombectomy with DAISe | Device: DAISe Device<br>* Thrombectomy using the DAISE device<br>|
| Active Comparator: Stent Retriever<br>Mechanical Thrombectomy with TREVO or Solitaire Device | Device: Trevo or Solitaire<br>* Thrombectomy using TREVO or Solitaire device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2 |  | 90 days | 
| Primary Safety Outcome: Symptomatic intracranial hemorrhage |  | 24hrs post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mTICI 2b-3 after randomized modality |  | procedure after use of randomized device | 
| mTICI 2b-3 after first attempt with randomized modality |  | procedure after first attempt with randomized device | 
| mTICI 2c-3 after randomized modality |  | procedure after use of randomized device | 
| mTICI 2c-3 after the first attempt with randomized modality |  | procedure after first attempt with randomized device | 
| mTICI 2b-3 at end of the procedure |  | procedure after all interventions | 
| mTICI 2c-3 at end of the procedure |  | procedure after all interventions | 
| Procedure Time | Time from groin puncture to first successful revascularization devices as mTICI 2b-3 flow (as long as final mTICI 2b-3 is achieved) | procedure | 
| Rates of procedure and/or device related serious adverse events |  | 90 days | 
| Rate of all intracranial hemorrhage at 24hrs |  | 24hrs | 
| Rate of embolization to a new vascular territory (ENT) during procedure |  | procedure | 
| All-cause mortality at 90 days |  | 90 days | 
| Neurologic/Stroke related mortality at 90 days |  | 90 days | 
| Patient reported outcome assessment by PROMIS Global-10 at 90 days |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DAISE, thrombectomy