Aventus Thrombectomy System Pulmonary Embolism Clinical Study

• Thrombectomy (Device): Use of Aventus Thrombectomy System to treat pulmonary embolism

Primary outcomes

• Change in RV/LV Ratio [at 48hrs compared to baseline]: Mean Change in RV (right ventricle)/LV(left ventricle) Ratio at 48hrs compared to baseline
• Device Related Major Adverse Event Rate [From Index Procedure to 48 hours]: Composite of device related MAEs (major adverse events) including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years
2. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
3. Subject is willing and able to comply with all protocol required follow-up visits
4. PE (pulmonary embolism) symptom(s) duration ≤ 14 days from index procedure
5. PE diagnosis ≤ 48 hours prior to index procedure
6. CTA (computed tomography angiography) evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
7. CTA evidence of dilated RV (right ventricle) with an RV/LV (left ventricle) ratio of ≥ 0.9 at baseline based on Investigator determination
8. Systolic blood pressure (SBP) ≥ 90 mmHg without need for vasopressors (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with intravenous fluids prior to index procedure)
9. Stable heart rate < 130 BPM prior to index procedure
10. Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment

Exclusion Criteria:

1. Prior PE ≤ 180 days from index procedure
2. Current hospitalization for other condition(s)
3. Thrombolytic use ≤ 14 days of baseline CTA
4. Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
5. FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
6. Hematocrit < 28% within 6 hours of index procedure
7. Platelets < 100,000/μL
8. Serum creatinine > 1.8 mg/dL
9. International normalized ratio (INR) > 3
10. Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
11. Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
12. Actively progressing cancer treated by chemotherapeutics
13. Known bleeding diathesis or coagulation disorder
14. Left bundle branch block
15. History of severe or chronic pulmonary arterial hypertension
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
17. History of uncompensated heart failure
18. History of underlying lung disease that is oxygen dependent
19. History of chest irradiation
20. History of heparin-induced thrombocytopenia (HIT)
21. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
23. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for aspiration thrombectomy intervention such as the inability to navigate to target location, predominantly chronic clot or non-clot embolus
24. Life expectancy of < 90 days, as determined by Investigator
25. Female who is pregnant or nursing
26. Current participation in another investigational drug or device treatment study that has not reached the primary endpoint or the Investigator feels would impact their ability to participate in this clinical trial
27. Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
28. Subject on extracorporeal membrane oxygenation (ECMO)

Participant flow

Outcome results

• Change in RV/LV Ratio (Primary), Mean, ratio: Single Arm .47 +/- .36
• Device Related Major Adverse Event Rate (Primary), Count of participants, Participants: Single Arm 0

Adverse events

Time frame: From enrollment until the end of follow-up, up to 30 days

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2024-03-28)
• Statistical Analysis Plan (PDF, 2024-11-13)

• Wissam Jaber, MD, Principal investigator, Emory University