RecruitingNot ApplicableNCT06152341

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

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

Sponsor

Akura Medical

Enrollment

30 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Pulmonary Embolism Acute

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).

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria8

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 Criteria26

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.