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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
RapidPulseTM Aspiration System
DeviceThe RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the occluded cerebral vasculature using precisely pulsed aspiration. The system is comprised of the multi-use, non-sterile RapidPulseTM Aspiration Pump, the single use, sterile RapidPulseTM Tube set, the single use, non-sterile RapidPulseTM Collection Canister and the single use, sterile RapidPulseTM 071 Catheter.
Treatment groups
170 Participants
are divided into 1 treatment groupGroup A: Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of First Pass Reperfusion Effect (FPE)
The proportion of patients who achieve First Pass Reperfusion Effect (FPE) as defined by mTICI ≥ 2c after the first pass
Time frame
Intra-procedural2
Rate of symptomatic intracranial hemorrhage (sICH)
The proportion of patients with symptomatic ICH (sICH) at 24 hours post-thrombectomy
Time frame
Post-procedural (24 hours post-thrombectomy)Secondary outcomes
1
Rate of reperfusion after all study device passes
Proportion of patients who achieve mTICI ≥ 2b within a maximum of 3 passes with Study Device
Time frame
Intra-procedural2
Modified Rankin Scale (mRS) at 90 days post treatment
Proportion of patients who achieve mRS ≤2 at 90-days post treatment.
Time frame
Post-procedure (90 days post-thrombectomy)Other outcomes
1
Rate of modified First Pass Reperfusion Effect (mFPE) after one reperfusion attempt
Modified First Pass Reperfusion Effect (mFPE) as defined by mTICI ≥ 2b after one device pass
Time frame
Intra-procedural2
Final reperfusion effect
Final mTICI ≥ 2b after all passes (including any rescue therapy) at procedure conclusion
Time frame
Intra-procedural3
Time to reperfusion
Time from arterial puncture (procedure initiation) to achieve mTICI ≥ 2b using first line aspiration treatment.
Time frame
Intra-procedural4
Rate of major early neurological recovery
Proportion of patients with major early neurological recovery at 24-hours as defined by reduction in National Institutes of Health Stroke Scale (NIHSS) score from baseline of at least 8 points or reaching NIHSS 0-1. \*NIHSS ranges from 0 to 42, with higher scores indicating greater neurological deficit.
Time frame
Post-procedure (24 hours post-thrombectomy)Sponsors and contacts
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Source ClinicalTrials.gov