Back to Clinical Trials
N/ARecruiting

The Pivotal Study of RapidPulseTM Aspiration System

Sponsored by RapidPulse, Inc

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.

The purpose of this prospective, open label clinical trials is to demonstrate the safety and effectiveness for the RapidPulseTM Aspiration System as frontline approach in the treatment of large vessel occlusions in patients experiencing Acute Ischemic Stroke within 8 hours of symptom onset or last seen normal. The target sample size for this clinical trial is 170 subjects enrolled in up to 30 sites globally. The maximum number of subjects that may be enrolled is 340. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on day 5-7 or hospital discharge (whichever comes first). The final study visit will occur approximately 90 days after the index event. The primary effectiveness endpoint is the proportion of patients who a…

Where this study is enrolling

Who can participate

Inclusion criteria

  • ✓Age 18 to 80 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)
  • ✕Alberta Stroke Program Early CT Score (ASPECTS) \<6
  • ✕Intracranial Atherosclerotic Disease (ICAD)
  • ✕Multiple or tandem occlusions
  • ✕Life expectancy less than 6 months

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.