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

Not Applicable

Withdrawn

• Conditions: Stroke, Ischemic; Stroke, Acute; Cerebrovascular Disorders; Cerebrovascular Accident; Stroke
• Interventions: Device: DAISe Device; Device: Trevo or Solitaire

• Registration Number: NCT04991038
• Lead Sponsor: MIVI Neuroscience, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-05
• Study Start: 2022-09
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAISe Thrombectomy Device	DAISe Device	Mechanical Thrombectomy with DAISe
Stent Retriever	Trevo or Solitaire	Mechanical Thrombectomy with TREVO or Solitaire Device

Primary Outcome Measures

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

Secondary Outcome Measures

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