Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke (PULSE-C)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Acute Ischemic Stroke; Large Vessel Occlusion; Mechanical Thrombectomy
• Intervention / Treatment: Device: RapidPulseTM Aspiration System

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Yang; Phone Number: 9498367402; Email: cyang@rapidpulsemed.com

Study Locations

• Georgia
  • Tbilisi, Georgia
    • National Institute of Surgery
    • Contact: Giorgi Egutidze, MD; Email: eguta1985@gmail.com
  • Tbilisi, Georgia
    • Pineo Medical Ecosystems
    • Contact: Alexander Tsiskaridze, MD; Email: alexander.tsiskaridze@tsu.ge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; 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.	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.; Other Names: Thrombectomy; Aspiration Thrombectomy

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontline technical success	The number of subjects with mTICI ≥ 2b after the last pass with Study Device (no rescue therapy)	Intra-procedural
Modified First Pass Reperfusion Effect (mFPE)	The number of subjects with mTICI ≥ 2b after one device pass	Intra-procedural
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 Day 5-7 or discharge whichever occurs earlier)
Final mTICI score	The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy)	Intra-procedural

Collaborators and Investigators

• Sponsor: RapidPulse, Inc
• Investigators: Study Chair: Raul G Nogueira, University of Pittsburgh Medical Center Stroke Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Mechanical Thrombectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: CIP-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No