Quadra-PE IDE STUDY
United States, Europe and Latin America
Clinical Trial ID:
NCT 06672510
Objective
The aim of this study is to evaluate the safety and effectiveness of the Akura Thrombectomy System to perform percutaneous mechanical thrombectomy in subjects with clinically significant acute pulmonary embolism.
Principal investigators
Sanjum Sethi, MD
Interventional Cardiologist, Columbia University Medical Center
Ann Gage, MD
Critical Care and Interventional Cardiologist, Tristar Centennial Medical Center
Study Design
Prospective, single-arm, interventional multicenter study
118 patients at up to 26 sites in US, EU (Austria) and Latin America (Brazil)
Follow-up at 48 hours and 30 days post thrombectomy procedure
Primary Endpoints
Effectiveness: Change in RV/LV ratio from baseline to 48 hours as assessed by CTA
Safety: Incidence of MAEs within 48 hours defined as a composite of device-related events that occur within 48 hours post-treatment
Key Inclusion Criteria
- The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
- Clinical signs, symptoms and presentation consistent with acute PE
- PE symptom duration ≤ 14 days
- CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
- CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator’s interpretation of RV/LV ratio at baseline)
- Systolic BP ≥ 90 mmHg (initial SBP may be < 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
Stable HR < 130 BPM prior to the procedure
Abbreviations: PE, pulmonary embolism; RV, right ventricular, LV, left ventricular; sPESI, simplified Pulmonary Embolism Severity Index
Status
Currently enrolling
