RecruitingAcute Ischemic Stroke

Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions

Eligible age

18–85 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

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About this study

The goal of this clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 8 hours of symptom onset or last seen normal. Subjects will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participation in the trial is for 90 days.

Sponsor: RapidPulse, Inc

You may qualify if…

✓ Age 18 to 85 years
✓ Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6
✓ Able to be treated within 8 hours of symptom onset or last known normal (LKN)
✓ Able to be treated within 120 minutes from the time of the qualifying baseline CT/MR image
✓ Pre-morbid Modified Rankin Scale (mRS) score 0-1
✓ Angiographic confirmation of large vessel occlusion (LVO) in the anterior (intracranial ICA or MCA M1 or M2 segments) or posterior circulation (vertebral or basilar arteries) as confirmed by digital subtraction angiography (DSA) irrespective of IV thrombolysis administration
✓ Candidate to receive treatment with ADAPT technique (Direct Aspiration First-Pass Technique)

You may not qualify if…

✕ Intracranial Hemorrhage (ICH)
✕ Significant mass effect and/or midline shift
✕ Alberta Stroke Program Early CT Score (ASPECTS) \<6 or (PC-ASPECTS \<8 on CT angiography source images or DWI MRI for posterior circulation stroke)
✕ Intracranial Atherosclerotic Disease (ICAD)
✕ Multiple or tandem occlusions
✕ Life expectancy less than 6 months