Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with Acute Pulmonary Embolism Patients undergoing mechanical thrombectomy for acute pulmonary embolism. |
Device: ATC System
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
|
Outcome Measures
Primary Outcome Measures
- Effectiveness [48 hours post index procedure]
Change in RV/LV ratio
- Safety: Composite of Major Adverse Device-Related Events [48 hours post index procedure]
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
Secondary Outcome Measures
- Safety: Composite of Major Adverse Events [30 days post index procedure]
Assessment of major adverse events through 30 day follow-up
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is ≥ 18 and ≤ 90 years old
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Clinical signs and symptoms consistent with acute PE for < 14 days
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CTA evidence of proximal PE
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RV/LV ratio > 0.9
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Systolic BP ≥90 mmHg without the need for vasopressors
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Stable heart rate (HR) < 130 BPM prior to procedure
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Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
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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:
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Prior PE < 180 days from index procedure
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Thrombolytic use < 30 days prior to baseline CTA
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Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
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FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
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Hematocrit <28%
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Platelets count <100,000/µL
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Serum creatinine >1.8 mg/dL
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International normalized ratio (INR) >3
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Major trauma injury severity score (ISS) >15 prior to screening assessment
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Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
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Cardiovascular or pulmonary surgery within 7 days of index procedure
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Actively progressing cancer treated by chemotherapeutics
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Known bleeding diathesis or coagulation disorder
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Left bundle branch block
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History of severe or chronic pulmonary arterial hypertension
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History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
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History of decompensated heart failure
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History of underlying lung disease that is oxygen dependent
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History of chest irradiation
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History of heparin-induced thrombocytopenia (HIT)
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Contraindication to systemic or therapeutic doses of anticoagulants
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Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
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Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
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Life expectancy <90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
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Female who is pregnant or nursing
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Current participation in another investigational drug or device treatment study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Akura Medical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CP-60003