CLEANer Aspiration for Pulmonary Embolism

Paused · Not applicable

Conditions studied: Pulmonary Embolism, Acute Pulmonary Embolism, Cardiovascular Diseases, Venous Thromboembolism

In brief

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

Key facts

Study ID

NCT06189313

Run by

Argon Medical Devices

People needed

125

Starts

2025-01-03

Expected to finish

2029-02-02

Last updated by the study team

2026-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• History of heparin-induced thrombocytopenia (HIT)
• Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding
• Recent (within one month) history of active bleeding from a major organ
• Absolute contraindication to anticoagulation
• Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days
• Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• Cardiovascular or pulmonary surgery within last 7 days
• Cancer which requires active chemotherapy
• Known serious, uncontrolled sensitivity to radiographic agents
• Life expectancy <90 days, as determined by investigator
• Female who is pregnant
• Intracardiac thrombus
• Patients who present with cardiac arrest and/or are on extracorporeal membrane oxygenation (ECMO) or ECMO required to perform interventional procedure
• Simultaneous participation in another investigational study
• Patients with known coagulation disorders such as antiphospholipid, Protein C, and Protein S

Where it is running

• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• Medstar Health Research Institute — Washington D.C., District of Columbia, United States
• BayCare Health System — Tampa, Florida, 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
• Promedica Toledo Hospital — Toledo, Ohio, United States
• Ascension St. John Jane Phillips Medical Center — Bartlesville, Oklahoma, United States
• Baylor Scott and White Heart and Vascular Hospital - Dallas — Dallas, Texas, United States
• Baylor Scott & White The Heart Hospital - Plano — Plano, Texas, United States

Full record on ClinicalTrials.gov

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