NCT05899036

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: RapidPulse, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke
• Stroke
• Large Vessel Occlusion
• Mechanical Thrombectomy

Interventions

Type	Name	Description
DEVICE	RapidPulseTM Aspiration System	The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.

Timeline

• Start date: 2024-03-23
• Primary completion: 2024-10-22
• Completion: 2024-10-27
• First posted: 2023-06-12
• Last updated: 2025-01-22

Locations

2 sites across 2 countries: Paraguay, Turkey (Türkiye)