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

Acute Ischemic Stroke Clinical Trial

— PULSE-F  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05577351
• Other study ID #: CIP-0004
• Status: Completed
• Phase: N/A
• Start date: April 23, 2023
• Est. completion date: June 13, 2023

Study information

• Verified date: April 2024
• Source: RapidPulse, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 13, 2023
• Est. primary completion date: June 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
Georgia	National Institute of Surgery	Tbilisi
Georgia	Pineo Medical Ecosystems	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
RapidPulse, Inc

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frontline Technical Success	As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy)	Intra-procedural
Other	Final mTICI	After all passes (including any rescue therapy)	Intra-procedural
Other	Modified First Pass Reperfusion Effect (mFPE)	Defined as mTICI 2b or greater after one device pass	Intra-procedural
Other	Device-related and procedure-related adverse events	Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm	Intra and post-procedural (up to 24 hours)
Primary	First Pass Reperfusion Effect (FPE)	Defined by mTICI greater than or equal to 2c after one reperfusion attempt	Intra-procedural