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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
Instituto do Coracao
São Paulo, São Paulo, Brazil
RECRUITINGInstituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
RECRUITINGCorazones Del Cibao
Santiago de los Caballeros, Santiago Province, Dominican Republic
Effectiveness
Change in RV/LV ratio
Time frame: 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
Time frame: 48 hours post index procedure
Safety: Composite of Major Adverse Events
Assessment of major adverse events through 30 day follow-up
Time frame: 30 days post index procedure
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Centro de Intervenciones Cardiovasculares
Santiago de los Caballeros, Santiago Province, Dominican Republic
RECRUITING