An interventional study of RapidPulseTM Aspiration System and Standard of Care Aspiration Thrombectomy System in Acute Ischemic Stroke, sponsored by RapidPulse, Inc. Completed at 5 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-02.
Sponsored by RapidPulse, Inc · Not applicable, Interventional, and Treatment
A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).
The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 80 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →RapidPulse, Inc is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.
Device: RapidPulseTM Aspiration System
Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.
Device: Standard of Care Aspiration Thrombectomy System
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Commercially available aspiration catheter with commercially available aspiration pump
First Pass Reperfusion Effect (FPE)
Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel
Time frame: Intra-procedural
Frontline technical success
Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy
Time frame: Intra-procedural
Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure
The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)
Time frame: 90 days
Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
Time frame: 24 hours
All cause mortality rate
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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RapidPulse, Inc