A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

NCT06042335 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 102699
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 20 subjects. A maximum of 5 investigational centers in Australia will participate. Enrollment is expected to take about 4 months, subject participation will last about 3 months.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• Successful revascularization

  Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.

  Peri-Procedural

• Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure

  Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.

  24 Hours [window: 12-36 hours] post procedure

Study Arms (1)

DAISe EZ

EXPERIMENTAL

Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.

Device: DAISe EZ

Interventions

DAISe EZ DEVICE

DAISe Thrombectomy System for mechanical thrombectomy

DAISe EZ

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 or older.
• Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-2.
• Diagnosis of acute ischemic stroke with study enrollment time \< 24 hours from onset of symptoms.
• Disabling stroke defined as a baseline NIHSS \> 6.
• Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery (ICA), MCA-M1 or MCA-M2.
• The following imaging criteria must also be met:
• For subjects 0-6hrs onset:
• MRI criterion: volume of diffusion restriction as assessed by automated core volume software ≤50 mL OR
• CT criterion: ASPECTS 6 to 10 on baseline CT or CTA-source images or, computed tomography perfusion (CPT) core as assessed by automated core volume software ≤50 mL.
• 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 representative

You may not qualify if:

• Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh hemorrhage on presentation.
• Clinical history, past imaging or clinical judgment suggests that the intracranial occlusion is chronic.
• Rapidly improving neurological deficits based on the investigator's clinical judgement.
• Pregnancy; if a woman is of child-bearing potential and urine or serum beta HCG test is positive.
• Severe contrast allergy or absolute contraindication to iodinated contrast.
• Difficult endovascular access, difficult aortic arch or severe neurovascular tortuosity that will result in an inability to deliver endovascular therapy.
• Evidence of dissection in the carotid or target artery for treatment.
• Presence of a carotid artery stenosis or occlusion requiring balloon angioplasty or stenting at time of the procedure.
• Renal failure (on dialysis).
• Severe, sustained hypertension resistant to treatment (SBP \>185 mmHg or DBP \>110 mmHg).
• Use of warfarin anticoagulation with International Normalized Ratio (INR) \> 3.0 at the time of the procedure or any known hemorrhagic or coagulation deficiency.
• Use of a direct thrombin inhibitor within the last 48 hours; partial thromboplastin time (PTT) \> 2.0 times the normal prior to procedure.
• Cerebral vasculitis or evidence of active systemic infection.
• Suspicion of aortic dissection, presumed septic embolus or suspicion of bacterial endocarditis.
• Clinical symptoms suggestive of bilateral stroke or occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).

Sponsors & Collaborators

• MIVI Neuroscience, Inc.: lead

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Stephanie Cihlar

CONTACT

763-227-7833; scihlar@mivineuroscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 18, 2023
• Study Start: July 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share