Loading clinical trials...

Aventus Thrombectomy System Pulmonary Embolism Clinical Study | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Evaluate the Safety and Efficacy of the Aventus Thrombectomy System for Aspiration Thrombectomy in Subjects With Acute Pulmonary Embolism

NCT05907564•Inquis Medical, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+18 more criteria

Locations (26)

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

Key Dates

Start Date

September 20, 2023

Primary Completion Date

February 20, 2025

Completion Date

October 1, 2026

Last Updated

February 4, 2026

Enrollment

130

ACTUAL participants

Conditions

Pulmonary EmbolismEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract Diseases

Interventions

Thrombectomy

DEVICE

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

NCT06183944

Pulmonary Embolism

View study

RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

NCT05963698

Atrial FibrillationStroke, Ischemic+1 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Aventus Thrombectomy System Pulmonary Embolism Clinical Study

Inclusion Criteria

Exclusion Criteria

Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

The Fourth Left Atrial Appendage Occlusion Study

CLEANer Aspiration for Pulmonary Embolism

REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)

Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking