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

NCT05899036 | Completed

• 1 other identifier: CIP-0003
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

Brief 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).

Conditions

Acute Ischemic Stroke; Stroke; Large Vessel Occlusion; Mechanical Thrombectomy

Keywords

Stroke; Mechanical Thrombectomy

Outcome Measures

Primary Outcomes (1)

• First Pass Reperfusion Effect (FPE)

  The number of subjects with mTICI ≥ 2c after one reperfusion attempt

  Intra-procedural

Other Outcomes (4)

• Frontline technical success

  Intra-procedural

• Final mTICI score

  Intra-procedural

• Modified First Pass Reperfusion Effect (mFPE)

  Intra-procedural

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

RapidPulseTM Aspiration System DEVICE

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.

Also known as: Aspiration Thrombectomy, Thrombectomy

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known or suspected ICAD
• Tandem occlusions

Sponsors & Collaborators

• RapidPulse, Inc: lead

Study Sites (2)

Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción

Asunción, Paraguay

Location

İstanbul Aydın Üniversitesi V.M Medical Park Florya Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raul G Nogueira

  University of Pittsburgh Medical Center Stroke Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-center, open-label, single-arm study to assess the initial technical (performance), effectiveness, and safety of the RapidPulseTM Aspiration System. As such, no formal statistical hypothesis will be tested in this study.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 12, 2023
• Study Start: March 23, 2024
• Primary Completion: October 22, 2024
• Study Completion: October 27, 2024
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1); TU (1)