Testing ASI-02 for right-to-left shunt

Exclusion

• −Allergy to polysorbate 80 (PS-80)
• −American Society of Anesthesiologists (ASA) physical status classification IV, V, or VI, except that participants with ASA physical status IV due solely to recent suspected transient ischemic attack or cerebrovascular accident are eligible for inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →
• −Current illness or pathology that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → would prevent undergoing investigational product administration due to a significant safety risk to the patient
• −Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)
• −Unstable cardiovascular status defined as:
• −myocardial infarction or unstable angina pectoris within 6 months prior to procedure day
• −symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
• −clinically significant congenital heart defects (excluding an atrial septal defect \[ASD\], patent foramen ovale \[PFO\], or pulmonary arteriovenous malformation \[PAVM\])
• −current uncontrolled cardiac arrhythmias causing clinical symptoms requiring medical intervention or hemodynamic compromise
• −acute pulmonary embolus or pulmonary infarction
• −acute myocarditis or pericarditis
• −acute aortic dissection
• −untreated atrial fibrillation
• −Participation in any investigational drug, device, or placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → study within 30 days prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
• −Vulnerable adult participant populations (e.g., incarcerated or cognitively challenged adults)
• −Female patients who are pregnant or lactating. All women of child-bearing potential (WOCBP) must have a negative urine pregnancy test at screening regardless of contraceptive use history
• −WOCBP are excluded unless they have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to ASI-02 dose administration
• −Any major surgery within 30 days prior to screening