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

NCT04991038 | Withdrawn DMC FDA Device

• 1 other identifier: 101903
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

DAISE; thrombectomy

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Outcome: Good Functional Outcome of Modified Rankin Score 0-2

  90 days

• Primary Safety Outcome: Symptomatic intracranial hemorrhage

  24hrs post procedure

Secondary Outcomes (13)

• 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

Study Arms (2)

DAISe Thrombectomy Device

EXPERIMENTAL

Mechanical Thrombectomy with DAISe

Device: DAISe Device

Stent Retriever

ACTIVE COMPARATOR

Mechanical Thrombectomy with TREVO or Solitaire Device

Device: Trevo or Solitaire

Interventions

DAISe Device DEVICE

Thrombectomy using the DAISE device

DAISe Thrombectomy Device

Trevo or Solitaire DEVICE

Thrombectomy using TREVO or Solitaire device

Stent Retriever

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share