Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients (RapidPulseFS)

  • STATUS
    Recruiting
  • End date
    Jan 12, 2023
  • participants needed
    30
  • sponsor
    RapidPulse, Inc
Updated on 12 July 2022

Summary

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).

Description

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.

Details
Condition Acute Ischemic Stroke
Treatment RapidPulseTM Aspiration System, Standard of Care Aspiration Thrombectomy System
Clinical Study IdentifierNCT05122637
SponsorRapidPulse, Inc
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or older
Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery

Exclusion Criteria

Evidence of hemorrhage
Significant mass effect and/or midline shift
Vessel tortuosity too difficult to allow endovascular access per investigator judgment
Severe or fatal co-morbidities
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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