Safety and Effectiveness of the ATC System in the Treatment of Acute PE
ConditionPulmonary Embolism Acute
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAkura Medical
About this trial
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).
Eligibility criteria
Qualifiers
Patient is ≥ 18 and ≤ 90 years old
Clinical signs and symptoms consistent with acute PE for < 14 days
CTA evidence of proximal PE
RV/LV ratio > 0.9
Disqualifiers
Prior PE < 180 days from index procedure
Thrombolytic use < 30 days prior to baseline CTA
Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
Trial design
Treatments tested in this trial
- ATC System
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
4Brazil
Instituto do Coracao05403-000, São PauloSão Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia04012-000, São Paulo Brazil
Dominican Republic
Centro de Intervenciones Cardiovasculares Santiago de los CaballerosSantiago Province, Dominican Republic
Corazones Del Cibao51000, Santiago de los CaballerosSantiago Province, Dominican Republic
Sponsors and collaborators
Akura Medical
Lead sponsor
Source ClinicalTrials.gov