Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Argon Medical Devices
With
NAMSA
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least 18 years of age at the time of consent
Clinical signs, symptoms, and presentation consistent with acute PE
Onset of PE symptoms occurred within 14 days of presentation
Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9
You may not be if
tPA use within 14 days prior to baseline CTA
Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
History of severe or chronic pulmonary hypertension
FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90%
Hematocrit \<28%
Platelets \<100,000/µL
Serum creatinine \>1.8 mg/dL
INR \>3
aPTT (or PTT) \>50 seconds on no anticoagulation
History of heparin-induced thrombocytopenia (HIT)
Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
Recent (within one month) history of active bleeding from a major organ
Absolute contraindication to anticoagulation
Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
Cardiovascular or pulmonary surgery within last 7 days
Cancer which requires active chemotherapy
Known serious, uncontrolled sensitivity to radiographic agents
Life expectancy \<90 days, as determined by investigator
Female who is pregnant
Intracardiac thrombus
Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
Simultaneous participation in another investigational study
Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S
Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization
Clareo Health | CLEANer Aspiration for Pulmonary Embolism
