Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients
NCT ID: NCT05122637
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2022-01-31
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm
RapidPulseTM Aspiration System with commercially available Medtronic React 71 aspiration catheter and commercially available aspiration pump as frontline approach thrombectomy technique.
RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Control Arm
Treatment with commercially available aspiration catheter with commercially available aspiration pump as frontline approach thrombectomy technique.
Standard of Care Aspiration Thrombectomy System
Commercially available aspiration catheter with commercially available aspiration pump
Interventions
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RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
Standard of Care Aspiration Thrombectomy System
Commercially available aspiration catheter with commercially available aspiration pump
Eligibility Criteria
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Inclusion Criteria
* 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
* Significant mass effect and/or midline shift
* Vessel tortuosity too difficult to allow endovascular access per investigator judgment
* Severe or fatal co-morbidities
18 Years
ALL
No
Sponsors
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RapidPulse, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Raul G Nogueira, MD
Role: STUDY_CHAIR
University of Pittsburgh Medical Center Stroke Institute
Locations
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General Hospital of Fortaleza
Fortaleza, , Brazil
Odense University Hospital
Odense, , Denmark
Pauls Stradiņš Clinical University Hospital
Riga, , Latvia
Hospital General Universitari d'Alicante
Alicante, , Spain
Istanbul Aydin University
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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DEV-0213
Identifier Type: -
Identifier Source: org_study_id
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