NCT05122637

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

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: 80 (actual)
• Sponsor: RapidPulse, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DEVICE	RapidPulseTM Aspiration System	The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
DEVICE	Standard of Care Aspiration Thrombectomy System	Commercially available aspiration catheter with commercially available aspiration pump

Timeline

• Start date: 2022-01-31
• Primary completion: 2022-09-23
• Completion: 2022-12-20
• First posted: 2021-11-17
• Last updated: 2023-03-02

Locations

5 sites across 5 countries: Brazil, Denmark, Latvia, Spain, Turkey (Türkiye)