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

Stroke Clinical Trial

— PULSE-C  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899036
• Other study ID #: CIP-0003
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: RapidPulse, Inc
• Contact: Cynthia Yang
• Phone: 9498367402
• Email: cyang[@]rapidpulsemed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Large Vessel Occlusion
• Mechanical Thrombectomy
• Stroke

Intervention

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.

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	The number of subjects with mTICI = 2b after the last pass with Study Device (no rescue therapy)	Intra-procedural
Other	Final mTICI score	The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy)	Intra-procedural
Other	Modified First Pass Reperfusion Effect (mFPE)	The number of subjects with mTICI = 2b 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 Day 5-7 or discharge whichever occurs earlier)
Primary	First Pass Reperfusion Effect (FPE)	The number of subjects with mTICI = 2c after one reperfusion attempt	Intra-procedural