RapidPulse(TM) Pivotal Study

This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.

To demonstrate the safety and effectiveness for the RapidPulse™ Aspiration System in the treatment of large vessel occlusions in patients experiencing an acute ischemic stroke. The RapidPulse™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive (LVO) disease (within the internal carotid, middle cerebral artery M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset (or last known normal). Patients who are ineligible for or failed intravenous thrombolytics are candidates for treatment.

Asterisks indicate entry criteria that may be evaluated during prescreening without obtaining informed consent form as they are part of standard of care in stroke management.

In order to participate you must meet the following general inclusion criteria:

• *Are 18 to 80 year of age.
• *Have a clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6.
• *Are able to be treated (i.e., defined by arterial puncture time) within 8 hours of symptom onset or last known normal (LKN).
• *Are able to be treated (i.e., defined by arterial puncture time) within 120 minutes from the time of the qualifying baseline CT/MR image.
• *Have a pre-morbid Modified Rankin Scale (mRS) score 0-1.
• *Have angiographic confirmation of large vessel occlusion (LVO) with TICI 0-1 flow in the anterior (intracranial internal carotid artery or middle cerebral artery M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration.
• *Are a candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique).
• Have signed Informed Consent obtained.

You will be excluded from the study if any of the following exclusion criteria apply to you:

• *Have imaging exclusions (based on CT/CTA, MR/MRA or DSA):
  • Presence of intracerebral hemorrhage
  • Significant mass effect and/or midline shift
  • ASPECTS <6 (or PC-ASPECTS <7 on CT angiography source images or DWI MRI for posterior circulation stroke)
  • If automated software is used, ischemic core lesion >50cc on CTP or >70cc on DWI-MRI
  • Evidence of intracranial tumor (except small meningioma)
  • Arterial stenosis proximal to the occlusion that could prevent thrombus removal and/or requiring stenting
  • Evidence of preexisting arterial injury or dissection
  • Vessel tortuosity too difficult to allow endovascular access per investigator judgement
  • Known or suspected ICAD
  • Evidence of multiple intracranial occlusions
  • Tandem occlusions
• *Have had recurrent strokes within the last 3 months.
• *Have uncontrolled hypertension.
  • Note: If the blood pressure can be successfully reduced and maintained at the acceptable level (per investigator judgement) using medication, the subject can be enrolled.
• *Have known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with INR >3.0.
• *Have a known platelet count <50,000 units/mcL.
• *Have a life expectancy of less than 6 months due to comorbidities.
• *Have a known pregnancy or are a woman in labor.
• *Have known or suspected vasculitis.
• *Are currently participating in an interventional drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
• *Have other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.