Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt (NCT06938347) | Clinical Trial Compass
RecruitingPhase 3
Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt
United States, Canada300 participantsStarted 2025-11-05
Plain-language summary
This is a phase 3, multicenter, open-label, blinded, crossover trial in which each participant will undergo a randomized sequence of ASI-02 and agitated saline standard of care (SoC) via a saline contrast transthoracic echocardiogram (TTE) study.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is clinically indicated for a saline contrast TTE study with a suspected right-to-left shunt
✓. Patient must be at least 18 years of age inclusive, at the time of signing the informed consent
✓. Able to communicate effectively with trial personnel
Exclusion criteria
✕. 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
✕. 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 inclusion
✕. Current illness or pathology that in the opinion of the investigator 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:
What they're measuring
1
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Timeframe: Procedure through 24- to 48-hour participant follow-up visit
2
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC
Timeframe: Procedure through 24- to 48-hour participant follow-up visit