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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Stroke; Cerebrovascular Disorders; Stroke, Ischemic; Stroke, Acute; Cerebrovascular Accident
• Intervention / Treatment: Device: DAISe Device; Device: Trevo or Solitaire

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DAISe Thrombectomy Device; Mechanical Thrombectomy with DAISe	Device: DAISe Device; Thrombectomy using the DAISE device
Active Comparator: Stent Retriever; Mechanical Thrombectomy with TREVO or Solitaire Device	Device: Trevo or Solitaire; Thrombectomy using TREVO or Solitaire device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: MIVI Neuroscience, Inc.
• Investigators: Principal Investigator: Adnan Siddiqui, MD, PhD, UB/Kaleida Health; Principal Investigator: Brian Jankowitz, MD, U Penn Medical Center; Principal Investigator: Luvas Elijovich, MD, University of Tennessee Health Sciences Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: thrombectomy; DAISE
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia; Cerebrovascular Disorders
• Other Study ID Numbers: 101903

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes