NCT05139147TerminatedNot Applicable
A Prospective, Multi-Center, Single Arm, Feasibility Study to Evaluate the DAISe Thrombectomy System During Neurointervention for Acute Ischemic Stroke; DAISe 1 Study
MIVI Neuroscience, Inc.10 sites in 1 country16 target enrollmentStarted: January 12, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- MIVI Neuroscience, Inc.
- Enrollment
- 16
- Locations
- 10
- Primary Endpoint
- Rate of symptomatic intracranial hemorrhage
Study Overview
Brief Summary
The study is a prospective, multi-center, single arm, feasibility study that will enroll a maximum of 36 subjects. The maximum enrollment is 10 subjects per site. A maximum of 6 investigational centers in Europe will participate. Enrollment is expected to take about 9 months, subject participation will last about 3 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Patient must be living in their own home, apartment or seniors lodge where no nursing care is required.
- •Diagnosis of acute ischemic stroke and referred to interventional neuroradiology center for mechanical thrombectomy with study enrollment time planned within 8 hours from onset of symptoms.
- •Disabling stroke defined as a baseline NIHSS >
- •Thrombolytic therapy (IV tPA) received within 4.5 hours of onset/ last known well according to prescribed dosing OR documented ineligibility for thrombolytic therapy.
- •Confirmed symptomatic, large vessel occlusion of the intracranial internal carotid artery, middle cerebral artery, M1, or M2 with mTICI 0-
- •The following baseline imaging criteria should be met: MRI criterion- volume of diffusion restriction visually assessed ≤50 mL OR ASPECTs score 5-10 or T criterion- ASPECTS 6-10 on imaging NE-CT, CTA and/or CTP available
- •Signed informed consent from patient or legal representative or if applicable, documented medical necessity for inclusion in a clinical study in an emergency followed by signed informed consent.
- •Patient is affiliated in the social security system.
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.
- •Renal failure (serum creatinine level ≥ 3 mg/dL or on dialysis).
- •Severe, sustained hypertension resistant to treatment (SBP >185 mmHg or DBP >110 mmHg).
- •Use of warfarin anticoagulation (or other applicable anti-vitamin k anticoagulants) 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).
- •Seizure due to stroke.
- •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.
- •A severe or fatal comorbid illness that will prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
- •Patient cannot undergo an MRI of the head due to MRI contraindication.
- •Patient is unable or unwilling complete follow up visits.
- •If before the stroke, the patient is under a legal protective measure, they will not be able to participate in the study.
Outcomes
Primary Outcomes
Rate of symptomatic intracranial hemorrhage
Time Frame: 12-36 hours
Symptomatic intracranial haemorrhage at 24 (+/-12) hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4
Rate of first pass revascularization success
Time Frame: procedure
First pass successful revascularization defined as mTICI (modified Treatment in Cerebral Ischemia) 2b-3 flow in the target vessel post-treatment with the DAISe Thrombectomy System used with aspiration.
Secondary Outcomes
- Infarct volume(12-36 hours)
- Rate of procedural final successful revascularization(Procedure)
- Rate of successful device use(Procedure)
- Mortality Rate(3 months)
- Rate of successful revascularization with the DAISe Device(Procedure)
- Rate of ENT(Procedure)
- Intracranial hemorrhage(12-36 hours)
- Procedure time(Procedure)
- Complications(Procedure)
- Good functional outcome(3 months)
- Rate of successful revascularization at procedure end(Procedure)
- Emboli(12-36 hours)
Investigators
Study Sites (10)
Loading locations...
Similar Trials
Terminated
Not Applicable
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the HipDegenerative Joint Disease of the HipNCT01982266Biomimedica, Inc4
Completed
Not Applicable
Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL SystemPeripheral Arterial DiseaseNCT05058456Shockwave Medical, Inc.35
Completed
Not Applicable
INVEST Feasibility - Minimally Invasive Endoscopic Surgery With Apollo in Patients With Brain HemorrhageIntracranial HemorrhageNCT02654015J. Mocco50
Terminated
Not Applicable
The Pristine Post-Market StudyHemodialysis ComplicationHemodialysis Catheter InfectionHemodialysis Access FailureCentral Venous Catheter Related Bloodstream InfectionEnd Stage Renal DiseaseKidney Failure, ChronicNCT05228132C. R. Bard142
Completed
Not Applicable
Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)Heavy Menstrual BleedingNCT06634719Rejoni Inc.13