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Thrombectomy Using Pulsed Aspiration for Reperfusion of Brain Occlusions

RecruitingNAAges 18 Years - 85 YearsAllRapidPulse, Inc
NCT06029491 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • RapidPulseTM Aspiration System
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Where

30 sites
Providence Saint John's Medical Foundation
Torrance, United States
Yale University
New Haven, United States
Baptist Health Research Institute
Jacksonville, United States
University of South Florida
Tampa, United States
Emory University at Grady
Atlanta, United States
Rush University Medical Center
Chicago, United States
Advocate Aurora Research Institute
Park Ridge, United States
Indiana University Health
Indianapolis, United States

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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