Идёт набор NCT06938347

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

Фаза III С лечением Right-To-Left Shunt

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Agitated Saline SoC, ASI-02.
Кому может быть актуально: Состояния в реестре: Right-To-Left Shunt. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Канада
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Open-label, Multicenter, Randomized Crossover Trial Comparing the Safety and Efficacy of ASI-02 to Agitated Saline for Suspected Right-to-left Shunt

Обзор

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.

Подробное описание

The primary objective is to determine the safety of ASI-02 and its agreement with agitated saline SoC for detection of right-to-left shunt in saline contrast studies utilizing TTE in the intended setting of use (opacifying the right heart). The investigation will be conducted in up to 8 investigational sites in the U.S. and Canada. Participants will receive n=2 ASI-02, n=4 agitated saline SoC injections as part of a single-day imaging session, with the overall duration for study participation of 24 to 48 hours.

Вмешательства

Препарат Agitated Saline SoC
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.
Препарат ASI-02
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.

Первичные конечные точки

Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]

Вторичные конечные точки (10)

The incidence of ASI-02-related adverse events [Срок оценки: 24- to 48-hour participant follow-up visit]
Peak opacification intensity [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Contrast opacification duration [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Positive percentage agreement (PPA) of ASI-02 for shunt detection at rest [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Negative percentage agreement (NPA) of ASI-02 for shunt detection at rest [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Positive percentage agreement (PPA) of ASI-02 for shunt detection specific to shunt sizes [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Negative percentage agreement (NPA) of ASI-02 for shunt detection specific to shunt sizes [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Test-retest reliability of agitated saline SoC [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Positive percentage agreement (PPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study. [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]
Negative percentage agreement (NPA) of ASI-02 for detecting right-to-left shunt versus agitated saline SoC, using the first (nonrandomized) SoC study. [Срок оценки: Procedure through 24- to 48-hour participant follow-up visit]

Критерии участия

Критерии включения

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

Критерии исключения

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:

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
Any major surgery within 30 days prior to screening
Participation in any investigational drug, device, or placebo study within 30 days prior to screening
Vulnerable adult participant populations (e.g., incarcerated or cognitively challenged adults)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет