An interventional study of RapidPulseTM Aspiration System in Acute Ischemic Stroke, Stroke and Large Vessel Occlusion, sponsored by RapidPulse, Inc. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by RapidPulse, Inc · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).
The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's enrollment of 19 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →RapidPulse, Inc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.
Device: RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.
Also known as: Aspiration Thrombectomy, Thrombectomy
First Pass Reperfusion Effect (FPE)
The number of subjects with mTICI ≥ 2c after one reperfusion attempt
Time frame: Intra-procedural
Frontline technical success
The number of subjects with mTICI ≥ 2b after the last pass with Study Device (no rescue therapy)
Time frame: Intra-procedural
Final mTICI score
The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy)
Time frame: Intra-procedural
Modified First Pass Reperfusion Effect (mFPE)
The number of subjects with mTICI ≥ 2b after one device pass
Time frame: Intra-procedural
Device-related and procedure-related adverse events
Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm
Time frame: Intra and post procedural (up to Day 5-7 or discharge whichever occurs earlier)
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2024 to primary completion in Oct 2024, 6 months.
Of 81 industry-sponsored interventional studies with no phase under Ischemic Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 46. This study's 6 months is below that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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RapidPulse, Inc