Clinical trial NCT05907564: Aventus Thrombectomy System Pulmonary Embolism Clinical Study
Official title: Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Keywords: Pulmonary Embolism
Clot
Thromboembolism
Thrombectomy
Right Heart Strain
Lead sponsor: Inquis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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 symptom(s) duration ≤ 14 days from index procedure
5. PE diagnosis ≤ 48 hours prior to index procedure
6. CTA 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 with an RV/LV ratio of ≥ 0.9 at baseline based on Investigator determination
8. 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)
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)

Primary outcomes:
measure: Change in RV/LV Ratio
timeFrame: From Baseline to 48 hours
measure: Major Adverse Event Rate
timeFrame: From Index Procedure to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Fairfield
country: United States
facility: NorthBay Medical Center
state: California
city: Long Beach
country: United States
facility: MemorialCare
state: California
city: Mountain View
country: United States
facility: El Camino Health
state: California
city: Sacramento
country: United States
facility: Sutter Health
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Washington
country: United States
facility: Medstar
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Ascension St. Vincent
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Bay City
country: United States
facility: McLaren Health Care
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Southfield
country: United States
facility: Ascension Providence
state: Michigan
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Ichan School of Medicine at Mount Sinai
state: New York
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Research Institute
state: Ohio
city: Toledo
country: United States
facility: ProMedica - Jobst Vascular
state: Ohio
city: Tulsa
country: United States
facility: Ascension St. John
state: Oklahoma
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Centennial Medical Center (HCA)
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton
state: Texas
Study officials:
affiliation: University Hospitals
name: Jun Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MedStar Health
name: Saher Sabri, MD
role: PRINCIPAL_INVESTIGATOR
References: