Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke; Stroke; Large Vessel Occlusion; Mechanical Thrombectomy
• Interventions: Device: RapidPulseTM Aspiration System

• Registration Number: NCT05899036
• Lead Sponsor: RapidPulse, Inc

Brief Summary

The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).

Detailed Description

The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety 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 target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-06-01
• Study First Posted: 2023-06-12
• Study Start: 2024-03-23
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-20
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours.
• CTA, MRA or DSA demonstrating anterior large vessel occlusion involving the intracranial ICA, MCA M1 or M2 segments, basilar or vertebral artery
• Target occlusion can be accessed by the RapidPulseTM 071 aspiration catheter assessed at the time of the index procedure. Enrollment will be defined by the successful navigation of the RapidPulseTM 071 aspiration catheter into the occlusion site.

Exclusion Criteria

• Known or suspected ICAD
• Tandem occlusions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	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 the thrombus in the neuro-vasculature using the RapidPulseTM Aspiration System.

Primary Outcome Measures

Name	Time	Method
First Pass Reperfusion Effect (FPE)	Intra-procedural	The number of subjects with mTICI ≥ 2c after one reperfusion attempt

Trial Locations

Locations (2)

Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción; 🇵🇾 Asunción, Paraguay

İstanbul Aydın Üniversitesi V.M Medical Park Florya Hastanesi; 🇹🇷 İstanbul, Turkey