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This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Acute Pulmonary Embolism | Experimental | Patients undergoing mechanical thrombectomy for acute pulmonary embolism. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATC System | Device | The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE |
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| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Change in RV/LV ratio | 48 hours post index procedure |
| Safety: Composite of Major Adverse Device-Related Events | Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury | 48 hours post index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Composite of Major Adverse Events | Assessment of major adverse events through 30 day follow-up | 30 days post index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rukhsana Khanum | Contact | +1 408-560-2500 | clinicalaffairs@akuramed.com | |
| Uday Illindala | Contact | +1 408-560-2500 | clinicalaffairs@akuramed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coracao | Recruiting | São Paulo | São Paulo | 05403-000 | Brazil |
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| Instituto Dante Pazzanese de Cardiologia | Recruiting | São Paulo | 04012-000 | Brazil |
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| Corazones Del Cibao | Not yet recruiting | Santiago de los Caballeros | Santiago Province | 51000 | Dominican Republic |
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| Centro de Intervenciones Cardiovasculares | Recruiting | Santiago de los Caballeros | Santiago Province | Dominican Republic |
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