Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study

Обзор

The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.

Подробное описание

The study objective is to evaluate the safety and effectiveness of the Vibrato™ Aspiration System Aspiration System (hereafter referred to as Vibrato™ Aspiration System) for aspiration mechanical thrombectomy in the treatment of acute PE.

The Vibrato™ Aspiration System is a vibration-assisted aspiration thrombectomy device including attributes designed to improve trackability, maintain a low-profile configuration, and operate without capital equipment. In addition, the Vibrato™ Aspiration System features a novel vibrating distal tip designed to enhance thrombus removal during aspiration while minimizing vascular injury. The vibrating mechanism may reduce procedure times, improve clot removal efficiency, and decrease the need for adjunctive interventions.

Вмешательства

• Устройство Mechanical Thrombectomy
  Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism

Первичные конечные точки

• Safety Endpoint: Major Adverse Events [Срок оценки: 48 hours]
• Efficacy Endpoint: Reduction in RV/LV Ratio [Срок оценки: 48 hours]

Вторичные конечные точки (12)

• Safety Endpoint: Device-Related Death [Срок оценки: 48 hours]
• Safety Endpoint: Major Bleeding [Срок оценки: 48 Hours]
• Safety Endpoint: Device-Related Clinical Deterioration [Срок оценки: 48 Hours]
• Safety Endpoint: Device-Related Pulmonary Vascular Injury [Срок оценки: 48 Hours]
• Safety Endpoint: Cardiac Injury [Срок оценки: 48 Hours]
• Safety Endpoint: Any-Cause Mortality [Срок оценки: 30 Days]
• Safety Endpoint: Device-Related Serious Adverse Event [Срок оценки: 30 Days]
• Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism [Срок оценки: 30 Days]
• Efficacy Endpoint: Modified Miller Index Score [Срок оценки: 48 Hours]
• Efficacy Endpoint: Change in Mean Pulmonary Artery Pressure [Срок оценки: Procedure]
• Efficacy Endpoint: Procedural Change in Cardiac Index [Срок оценки: Procedure]
• Efficacy Endpoint: Length of ICU Stay, Associated with Index Procedure [Срок оценки: 30 Days]

Критерии участия

Критерии включения

Subjects must meet all following general inclusion criteria:

• Age ≥ 18 and ≤ 75 years.
• Clinical signs, symptoms, and presentation consistent with acute PE;
• PE symptom duration ≤ 14 days;
• CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
• RV/LV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined).
• Systolic blood pressure ≥ 90 mmHg;
• Stable heart rate < 130 BPM prior to procedure;
• Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment
• Informed Consent Form signed
• Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit

Критерии исключения

Subjects must not meet any of the following general exclusion criteria:

• Thrombolytic use within 30 days of baseline CT angiogram
• Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
• Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%;
• Hematocrit < 28%;
• Platelets < 100,000/ML;
• Serum creatinine > 1.8 mg/dL;
• International normalized ratio (INR) > 3;
• Major trauma injury severity score (ISS) > 15 within the past 14 days
• Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;
• Cardiovascular or pulmonary surgery within last 7 days;
• Actively progressing cancer requiring chemotherapy
• Known bleeding diathesis or coagulation disorder;
• Left bundle branch block;
• History of severe or chronic pulmonary arterial hypertension;
• History of chronic left heart disease with left ventricular ejection fraction ≤ 30%;
• History of uncompensated heart failure;
• History of underlying lung disease that is oxygen dependent;
• History of chest irradiation;
• History of heparin-induced thrombocytopenia (HIT);
• Patients who are under intubation
• Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;
• Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;
• Life expectancy of < 90 days, as determined by Investigator;
• Female who is pregnant or nursing;
• Current participation in another investigational drug or device treatment study
• History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
• Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Польша · 2 центра

• Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny — Poznan
• Krakowski Szpital Specjalistyczny im. św. Jana Pawła II — Krakow

Идентификаторы

NCT: NCT07685522 · 26-VIC-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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