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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
ATC System
DeviceThe ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients with Acute Pulmonary EmbolismExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness
Change in RV/LV ratio
Time frame
48 hours post index procedure2
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 procedureSecondary outcomes
1
Safety: Composite of Major Adverse Events
Assessment of major adverse events through 30 day follow-up
Time frame
30 days post index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov