Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke

NCT05577351 — Not applicable, Completed, 5 participants, RapidPulse, Inc

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PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions

Registry	NCT05577351, acronym PULSE-F
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, device feasibility
Enrollment	5 (Actual)
Sponsor	RapidPulse, Inc (Industry)
Conditions	Acute Ischemic Stroke
Interventions	RapidPulseTM Aspiration System (Device)
Dates	start 2023-04-23, primary completion 2023-06-03, completion 2023-06-13, first posted 2022-10-13, last updated 2024-04-23
Locations	2 sites in Georgia

-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) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

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+Detailed description

The purpose of this prospective, open label clinical trial is to assess the initial safety and performance 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 study will enroll up to a maximum of 50 subjects in 2 centers in Georgia. Subjects will undergo mechanical thrombectomy procedure and will have post-operative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Arm	Experimental	Device: RapidPulseTM Aspiration System	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 thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.

RapidPulseTM Aspiration System (Device), also known as Aspiration Thrombectomy: The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System

+Outcome measures

Primary outcomes

First Pass Reperfusion Effect (FPE) [Intra-procedural]: Defined by mTICI greater than or equal to 2c after one reperfusion attempt

Other outcomes

Frontline Technical Success [Intra-procedural]: As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy)
Final mTICI [Intra-procedural]: After all passes (including any rescue therapy)
Modified First Pass Reperfusion Effect (mFPE) [Intra-procedural]: Defined as mTICI 2b or greater after one device pass
Device-related and procedure-related adverse events [Intra and post-procedural (up to 24 hours)]: Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
* Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
* Target occlusion can be accessed by the Medtronic React 71 aspiration catheter

Exclusion Criteria:

* Known or suspected intracranial atherosclerotic disease (ICAD)
* Tandem occlusions

+Locations (2)

Facility	City	Country	Status
National Institute of Surgery	Tbilisi	Georgia
Pineo Medical Ecosystems	Tbilisi	Georgia

+Investigators

Raul G Nogueira, MD, Study chair, University of Pittsburgh Medical Center Stroke Institute