A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific

Overview

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.

Interventions

• Device DAISe EZ
  DAISe Thrombectomy System for mechanical thrombectomy

Primary outcome measures

• Successful revascularization [Time frame: Peri-Procedural]
• Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure [Time frame: 24 Hours [window: 12-36 hours] post procedure]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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).
• A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06042335 · 102699

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗