Status:
RECRUITING
CLEANer Aspiration for Pulmonary Embolism
Lead Sponsor:
Argon Medical Devices
Collaborating Sponsors:
NAMSA
Conditions:
Pulmonary Embolism
Acute Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Eligibility Criteria
Inclusion
- 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
- 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 or suspected undiagnosed pulmonary hypertension with peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A)
- 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
- Morbidly obese (BMI \>50 kg/m2) patient who by the judgement of the investigator is high risk for bleeding
- 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
- Presentation of PE with paradoxical emboli which may be diagnosed by concurrent stroke or concurrent arterialization
Key Trial Info
Start Date :
January 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 23 2026
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06189313
Start Date
January 3 2025
End Date
September 23 2026
Last Update
August 26 2025
Active Locations (16)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Medstar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
3
Ascension Sacred Heart Hospital
Pensacola, Florida, United States, 32504
4
Insight Hospital and Medical Center
Chicago, Illinois, United States, 60616