Health TrialsbyHealthPanel

Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

ConditionRight-To-Left Shunt
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAgitated Solutions, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Agitated Saline SoC

    Drug

    The recommended initial dose of agitated saline SoC is approximately 10 mL of saline containing approximately 1 mL of air, per institutional policy, rapidly mixed (approximately 10-20 presses) to manufacture microbubbles. No additives are allowed to the saline, including blood, dextrose, or bacteriostatic saline.

  • ASI-02

    Drug

    Each injection shall utilize one (1) ASI-02 product connected to one (1) pre-filled 10 mL 0.9% sodium chloride (saline) syringe. The ASI-02 investigational product will be connected to a standard luer lock connector and administered in its entirety. The intravenous bolus injected dose of ASI-02 is 9 mL of saline and 1 mL of air.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Standard of Care to ASI-02 TTE StudyExperimental treatment 2 interventions
Group B: ASI-02 to Standard of Care TTE StudyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC

Time frame
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

Time frame
Procedure through 24- to 48-hour participant follow-up visit

Secondary outcomes

1

The incidence of ASI-02-related adverse events

Time frame
24- to 48-hour participant follow-up visit
2

Peak opacification intensity

Time frame
Procedure through 24- to 48-hour participant follow-up visit
3

Contrast opacification duration

Time frame
Procedure through 24- to 48-hour participant follow-up visit
4

Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest

Time frame
Procedure through 24- to 48-hour participant follow-up visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Agitated Solutions, Inc.

Lead sponsor

Bright Research Partners

Collaborator

Source ClinicalTrials.gov
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