Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Running, not enrolling · Not applicable

Conditions studied: Pulmonary Embolism, Embolism, Embolism and Thrombosis, Vascular Diseases, Cardiovascular Diseases, Lung Diseases, Respiratory Tract Diseases

In brief

Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.

Key facts

Study ID

NCT05907564

Run by

Inquis Medical, Inc.

People needed

130

Starts

2023-09-20

Expected to finish

2026-10-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and ≤ 80 years
• 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
• Subject is willing and able to comply with all protocol required follow-up visits
• 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)
• CTA evidence of dilated RV with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
• Systolic blood pressure ≥ 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)
• Stable heart rate < 130 BPM prior to index procedure
• Subject is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment

You may not qualify if…

• Prior PE ≤ 180 days from index procedure
• Current hospitalization for other condition(s)
• Thrombolytic use ≤ 14 days of baseline CTA
• Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• Hematocrit < 28% within 6 hours of index procedure
• Platelets < 100,000/μL
• Serum creatinine > 1.8 mg/dL
• International normalized ratio (INR) > 3
• Presence of intracardiac lead in the right ventricle or right atrium placed < 180 days prior to index procedure
• Cardiovascular or pulmonary surgery ≤ 7 days prior to index procedure
• Actively progressing cancer treated by chemotherapeutics
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• 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
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT)
• Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 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
• Life expectancy of < 90 days, as determined by Investigator
• Female who is pregnant or nursing

Where it is running

• Honor Health — Scottsdale, Arizona, United States
• NorthBay Medical Center — Fairfield, California, United States
• MemorialCare — Long Beach, California, United States
• El Camino Health — Mountain View, California, United States
• Sutter Health — Sacramento, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Medstar — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Ascension St. Vincent — Indianapolis, Indiana, United States
• Ochsner Health — New Orleans, Louisiana, United States
• McLaren Health Care — Bay City, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Ascension Providence — Southfield, Michigan, United States
• CentraCare Heart and Vascular — Saint Cloud, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Holy Name Medical Center — Teaneck, New Jersey, United States
• Ichan School of Medicine at Mount Sinai — New York, New York, United States
• University Hospitals — Cleveland, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• ProMedica - Jobst Vascular — Toledo, Ohio, United States
• Ascension St. John — Tulsa, Oklahoma, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Centennial Medical Center (HCA) — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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