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Completed

NCT Number: NCT05577351

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Surgery, Tbilisi, Georgia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RapidPulseTM Aspiration System

Device

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

Other names: Aspiration Thrombectomy

Primary outcomes

  1. First Pass Reperfusion Effect (FPE)

    Time frame: Intra-procedural

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

Other outcomes

  1. Frontline Technical Success

    Time frame: Intra-procedural

    As defined by mTICI 2b or greater after the last pass with Study Device (no rescue therapy)

  2. Final mTICI

    Time frame: Intra-procedural

    After all passes (including any rescue therapy)

  3. Modified First Pass Reperfusion Effect (mFPE)

    Time frame: Intra-procedural

    Defined as mTICI 2b or greater after one device pass

  4. Device-related and procedure-related adverse events

    Time frame: Intra and post-procedural (up to 24 hours)

    Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm

Sponsors and collaborators

Lead sponsor

RapidPulse, Inc

Industry

Registry information

Official study title

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

Acronym: PULSE-F

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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