PULSE-F: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke

Sponsor

RapidPulse, Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05577351

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Device: RapidPulseTM Aspiration System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Arm 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.	Device: RapidPulseTM Aspiration System The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System Other Names: Aspiration Thrombectomy

Arm

Intervention/Treatment

Experimental: Treatment Arm

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.

Device: RapidPulseTM Aspiration System

The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System

Other Names:

Aspiration Thrombectomy

Outcome Measures

Primary Outcome Measures

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

Other Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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