Aventus Thrombectomy System Pulmonary Embolism Clinical Study
- Conditions
- Cardiovascular DiseasesPulmonary EmbolismEmbolismEmbolism and ThrombosisVascular DiseasesRespiratory Tract DiseasesLung Diseases
- Interventions
- Device: Thrombectomy
- Registration Number
- NCT05907564
- Lead Sponsor
- Inquis Medical, Inc.
- Brief Summary
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
- 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
- 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
- Subject has known residual Iliac Deep Vein Thrombosis (DVT), Inferior Vena Cava (IVC) clot or clot in transit (right atrium and/or right ventricular)
- Subject on extracorporeal membrane oxygenation (ECMO)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Thrombectomy Device: Aventus Thrombectomy System
- Primary Outcome Measures
Name Time Method Change in RV/LV Ratio From Baseline to 48 hours Change in RV/LV Ratio per CTA
Major Adverse Event Rate From Index Procedure to 48 hours Composite of device related MAEs including death, major bleed, clinical deterioration, pulmonary vascular injury, and cardiac injury
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Sutter Health
🇺🇸Sacramento, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Ochsner Health
🇺🇸New Orleans, Louisiana, United States
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
Medstar
🇺🇸Washington, 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
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
Ascension Seton
🇺🇸Austin, Texas, United States