AVENTUS: Assessing the Safety and Efficacy of the treatment for Acute Pulmonary Embolism using the Inquis Medical Aventus Thrombectomy System

Study Type/Phase: Prospective, Single Group Assignment, Safety & Efficacy
Status: Recruiting

Pulmonary embolism (PE) is a major cause of morbidity and mortality that occurs when particles/thrombi that have formed within the blood stream are dislodged and travel to the lung causing a reduced ability to breathe and a reduced total ventilatory capacity. This is why symptoms of PE include acute shortness of breath, chest discomfort, palpitations, dyspnea, dizziness or syncope, extremity pain, or swelling. Because the lung has less volume due to the thrombi blockage (embolism), some of the blood pumped in the lung backflows into the heart (right ventricle). This causes the heart to experience pressure overload which can lead to death in severe cases.

Currently, the following clinical options are used in the treatment of PE: anticoagulation therapy, surgical embolectomy, thrombolytic therapy, catheter-directed thrombolysis and mechanical thrombectomy. Inquis Medical, Inc. has created an aspiration thrombectomy device called the Aventus Thrombectomy System which is being tested for its safety and efficacy in this study. The target study population are subjects presenting with symptoms of acute intermediate risk PE defined as having clinical signs and symptoms 14 days or less from the index procedure with an RV/LV ratio of ≥ 0.9 on CT angiography, systolic BP ≥ 90 mmHg, and who are indicated for treatment with aspiration thrombectomy. The primary goal of this study, in addition to increasing patient safety, is to verify a change in RV/LV ratio from Baseline (≥ 0.9) to 48 hours (±8 hours) post-index procedure, as measured by CT angiography.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion CriteriaExclusion Criteria
  • PE symptom(s) duration ≤ 14 days from index procedure
  • PE diagnosis ≤ 48 hours prior to index procedure
  • CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery based on Investigator determination)
  • Prior PE ≤ 180 days from index procedure
  • Thrombolytic use ≤ 14 days of baseline CTA
  • History of severe or chronic pulmonary arterial hypertension
  • History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
  • History of uncompensated heart failure
  • History of underlying lung disease that is oxygen dependent

Principal Investigator

Fabio Komlos, MD

Sponsor

Inquis Medical, Inc.

NCT Number

05907564

Contact

Dawn Ysmael, Clinical Research Coordinator
650-962-4463
Dawn_Ysmael@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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