Safety and Effectiveness of the ATC System in the Treatment of Acute PE

Study Overview
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Brief Summary
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This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).

Official Title
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Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism Acute

Intervention / Treatment
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* Device: ATC System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 18 and ≤ 90 years old Clinical signs and symptoms consistent with acute PE for < 14 days CTA evidence of proximal PE RV/LV ratio > 0.9 Systolic BP ≥90 mmHg without the need for vasopressors Stable heart rate (HR) < 130 BPM prior to procedure Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures Exclusion Criteria: Prior PE < 180 days from index procedure Thrombolytic use < 30 days prior to baseline CTA Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90% Hematocrit <28% Platelets count <100,000/µL Serum creatinine >1.8 mg/dL International normalized ratio (INR) >3 Major trauma injury severity score (ISS) >15 prior to screening assessment Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment Cardiovascular or pulmonary surgery within 7 days of index procedure Actively progressing cancer treated by chemotherapeutics 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 decompensated heart failure History of underlying lung disease that is oxygen dependent History of chest irradiation History of heparin-induced thrombocytopenia (HIT) Contraindication to systemic or therapeutic doses of anticoagulants Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention Life expectancy <90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections Female who is pregnant or nursing Current participation in another investigational drug or device treatment study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with Acute Pulmonary Embolism<br>Patients undergoing mechanical thrombectomy for acute pulmonary embolism. | Device: ATC System<br>* The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness | Change in RV/LV ratio | 48 hours post index procedure | 
| Safety: Composite of Major Adverse Device-Related Events | Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury | 48 hours post index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Composite of Major Adverse Events | Assessment of major adverse events through 30 day follow-up | 30 days post index procedure |