Skip to main content
Clinical Trials/NCT05577351
NCT05577351CompletedNot Applicable

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

RapidPulse, Inc2 sites in 1 country5 target enrollmentStarted: April 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
5
Locations
2
Primary Endpoint
First Pass Reperfusion Effect (FPE)

Study Overview

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.

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
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

First Pass Reperfusion Effect (FPE)

Time Frame: Intra-procedural

Defined by mTICI greater than or equal to 2c after one reperfusion attempt

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials