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NCT Number: NCT05122637

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

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).

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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

General Hospital of Fortaleza, Fortaleza, Brazil

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About this study

The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Age 18 years or older
  • Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
  • Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery

Key Exclusion Criteria:

  • Evidence of hemorrhage
  • Significant mass effect and/or midline shift
  • Vessel tortuosity too difficult to allow endovascular access per investigator judgment
  • Severe or fatal co-morbidities

Treatment and study plan

RapidPulseTM Aspiration System

Device

The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.

Standard of Care Aspiration Thrombectomy System

Device

Commercially available aspiration catheter with commercially available aspiration pump

Primary outcomes

  1. First Pass Reperfusion Effect (FPE)

    Time frame: Intra-procedural

    Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel

Secondary outcomes

  1. Frontline technical success

    Time frame: Intra-procedural

    Defined by mTICI ≥ 2b after the last pass with Study Device with no rescue therapy

  2. Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure

    Time frame: 90 days

    The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)

  3. Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure

    Time frame: 24 hours

  4. All cause mortality rate

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

RapidPulse, Inc

Industry

Registry information

Official study title

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

Acronym: RapidPulseFS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Mar 2, 2023

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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