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

NCT ID: NCT04991038

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-09-30

Brief Summary

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

Conditions

Stroke; Stroke, Ischemic; Stroke, Acute; Cerebrovascular Disorders; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DAISe Thrombectomy Device

Mechanical Thrombectomy with DAISe

Group Type: EXPERIMENTAL

DAISe Device

Intervention Type: DEVICE

Thrombectomy using the DAISE device

Stent Retriever

Mechanical Thrombectomy with TREVO or Solitaire Device

Group Type: ACTIVE_COMPARATOR

Trevo or Solitaire

Intervention Type: DEVICE

Thrombectomy using TREVO or Solitaire device

Interventions

DAISe Device

Thrombectomy using the DAISE device

Intervention Type: DEVICE

Trevo or Solitaire

Thrombectomy using TREVO or Solitaire device

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MIVI Neuroscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adnan Siddiqui, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UB/Kaleida Health

Brian Jankowitz, MD

Role: PRINCIPAL_INVESTIGATOR

U Penn Medical Center

Luvas Elijovich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee Health Sciences Center

Other Identifiers

101903

Identifier Type: -

Identifier Source: org_study_id