Stroke, Acute
Conditions
Keywords
Mechanical thrombectomy, Acute ischemic stroke, neurovascular intervention
Brief summary
This purpose study is to demonstrate the safety and performance of the DAISe System used to remove clot in the brain during a stroke. This study will assess how well the device removes clot from the brain and how well patients recover from their stroke. This study plans to enroll 100 study patients at up to 10 hospitals in Europe. Study patients are followed for 3 months after the procedure.
Detailed description
The study is a prospective, multi-center, single arm study that will enroll a maximum of 90 subjects, plus up to 50 roll-in subjects. A maximum of 10 sites in Europe will be involved in this study. The primary performance endpoint is successful revascularization defined as TICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. The primary safety endpoint is symptomatic intracranial haemorrhage at 24 hours post-procedure as detected by CT/MRI with an NIHSS change of \>/=4. Subject will be followed through hospital discharge with a visit at Day 1 post procedure, Day 7 or prior to discharge/transfer, 30 days and 3 months.
Interventions
DEVICEDAISe System
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
Sponsors
MIVI Neuroscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 85 years. * Diagnosis of acute ischemic stroke with study enrollment time \< 8 hours from onset of symptoms. * Disabling stroke defined as a baseline NIHSS \> 6. * Pre-stroke (24 hours prior to stroke onset) independent functional status in activities of daily living with modified Rankin Score 0-1. * If thrombolytic therapy (tPA) is administered, it must be administered per the prescribing information. * Confirmed symptomatic intracranial occlusion, based on single phase, multiphase or dynamic CTA, at one or more of the following locations: Carotid T/L, M1 MCA, or M1-MCA equivalent (2 or more M2-MCAs), or M2-MCA. * The following baseline imaging criteria should be met: MRI criterion: ASPECTS Score \> 4 OR CT criterion: ASPECTS \> 6 * Signed informed consent from patient or legally authorized representative.
Exclusion criteria
* CT or 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 * Severe contrast allergy or absolute contraindication to iodinated contrast. * No femoral pulses or very difficult endovascular access that will result in an inability to deliver endovascular therapy. * Evidence of dissection in the carotid or middle cerebral arteries. * Severe unilateral or bilateral carotid artery stenosis requiring treatment at the time of the procedure as determined during diagnostic angiography. * Renal failure (serum creatinine level ≥ 4 mg/dL or on dialysis). * Severe, sustained hypertension (SBP \>185 mmHg or DBP \>110 mmHg). * Cerebral vasculitis. * 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. * Platelet count \< 50,000/mm3. * 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 is unable or unwilling complete follow up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with successful revascularization | intra-procedural | Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System. |
| Rate of symptomatic intracranial haemorrhage | 12-36 hours post procedure | 24 hours post-procedure as detected by CT/MRI with an NIHSS change of \>4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of embolization to a new vascular territory (ENT) | intra-procedural | — |
| Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System | intra-procedural | — |
| Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System | intra-procedural | — |
| Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow | intra-procedural | — |
| Good functional outcome for participants measured by Modified Rankin Scale score of 0-2. | 30 days and 3 months post procedure | The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased). |
| Quality of life for participants: PROMIS Scale | 3 months post procedure | PROMIS Scale |
| Rate of all cause mortality | 30 days and 3 months post procedure | — |
| Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure | intra-procedural | — |
| Rate of procedure-related complications | post procedure through discharge | — |
Countries
Belgium
Outcome results
None listed