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 groupSponsors and collaborators
Source ClinicalTrials.gov