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The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
The Feasibility Study SA is a prospective, single-arm, interventional multi-center study enrolling up to 100 treated subjects.
The Supira Catheter is a single-use percutaneous expandable blood pump designed to unload the left ventricle by actively transporting blood from the left ventricle into the aorta.
The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRPCI patients | Experimental | Patients undergoing non-emergent, high-risk percutaneous coronary interventions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supira System | Device | The Supira System is a temporary (≤ 4 hours) ventricular support device indicated for use during elective or urgent high-risk percutaneous coronary interventions (HRPCI) performed in hemodynamically stable patients with severe coronary artery disease when a heart team has determined HRPCI is the appropriate therapeutic option. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Feasibility Endpoint: Successful initiation and maintenance of hemodynamic support without sustained hypotension throughout the index procedure. | Sustained hypotension is defined as sustained mean arterial pressure (MAP) < 60mmHg requiring (1) more than one administration of inotropes/vasopressors within 5 minutes, OR (2) continuous infusion of inotropic/pressor medications, OR 3) alternative mechanical circulatory support, to restore hemodynamics. | From device delivery through device removal (up to 4 hours). |
| Primary Safety Endpoint: Rate of composite major device-related adverse events (MDRAEs), from device delivery through device removal. | MDRAEs related to the device. | From device delivery through device removal (up to 4 hours). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Technical Success. | Completion of the entire Supira System procedure, including delivery, operation without device malfunction, and successful retrieval of the catheter. | From device delivery through device removal (up to 4 hours). |
| Rate of Procedural Success |
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To be eligible, subjects must meet ALL of the following inclusion criteria:
To be eligible, subjects must NOT meet ANY of the following exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Dante Pazzanese De Cardiologia (Dante) | São Paulo | 04012-909 | Brazil | |||
| 'Instituto Do Coração de São Paulo (InCor)' |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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Feasibility Study
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|
Rate of technical success without procedural serious adverse events (SAEs). |
| From device delivery through device removal (up to 4 hours). |
| Rate of composite MDRAEs from device removal through hospital discharge or 72 hours post-procedure, whichever comes first. | MDRAEs related to the study device. | From device removal through hospital discharge or 72 hours post-procedure, whichever occurs first. |
| Rate of composite MDRAE from hospital discharge or 72 hours post-procedure (whichever occurs first) through 30 days post device removal. | Major adverse events related to the study device. | From hospital discharge or 72 hours post-procedure (whichever occurs first) |
| Rate of composite MDRAE from 30 days to 90 days post device removal (for subjects enrolled and treated after the first 30 subjects). | Major adverse events related to the device. | From 30 days to 90 days post device removal. |
| São Paulo |
| 5403-000 |
| Brazil |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |