The Pivotal Study of RapidPulseTM Aspiration System
ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRapidPulse, Inc
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Intracranial Hemorrhage (ICH)
Alberta Stroke Program Early CT Score (ASPECTS) <6
Intracranial Atherosclerotic Disease (ICAD)
Multiple or tandem occlusions
Trial design
Treatments tested in this trial
- RapidPulseTM Aspiration System
Treatment groups
170 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov