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CLEANer Aspiration for Pulmonary Embolism | Clinical Trials | Clareo Health

RECRUITINGNA

CLEANer Aspiration for Pulmonary Embolism

A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism

NCT06189313•Argon Medical Devices

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 18 years of age at the time of consent
•Clinical signs, symptoms, and presentation consistent with acute PE
•Onset of PE symptoms occurred within 14 days of presentation
•Filling defect in at least one main or lobar pulmonary artery evidenced by CTA
•RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9

Exclusion Criteria

•tPA use within 14 days prior to baseline CTA
•Systolic BP \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg
•Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
•History of severe or chronic pulmonary hypertension
•FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90%
•Hematocrit \<28%
•Platelets \<100,000/µL
•Serum creatinine \>1.8 mg/dL
•INR \>3
•aPTT (or PTT) \>50 seconds on no anticoagulation
+16 more criteria

Locations (14)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Medstar Health Research Institute

Washington D.C., District of Columbia, United States

Ascension Sacred Heart Hospital

Pensacola, Florida, United States

BayCare Health System

Tampa, Florida, United States

Insight Hospital and Medical Center

Chicago, Illinois, United States

Ascension St. Vincent Hospital

Indianapolis, Indiana, United States

UMass Chan Medical School

Worcester, Massachusetts, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

University of Cincinnati

Cincinnati, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

January 3, 2025

Primary Completion Date

June 4, 2027

Completion Date

September 2, 2027

Last Updated

March 12, 2026

Enrollment

125

ESTIMATED participants

Conditions

Pulmonary EmbolismAcute Pulmonary EmbolismCardiovascular DiseasesVenous Thromboembolism

Interventions

Cleaner Pro Thrombectomy System

DEVICE

Contacts

Danyel C Carr, MS

CONTACT

4697311421 Clinical@argonmedical.com

Holly Harrison

CONTACT

4697313561

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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: March 12, 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.

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CLEANer Aspiration for Pulmonary Embolism

Inclusion Criteria

Exclusion Criteria

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