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

S
Sabah D. Butty, MD

Primary Investigator

Administratively Closed
18 years - 100 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

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

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

PRIMARY OUTCOMES:

  • Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
  • Rate of Major Adverse Events (MAEs)

SECONDARY OUTCOMES:

  • Rate of device-related complications and device-related death
  • Rate of device-related SAEs and all-cause mortality
  • Rate of Symptomatic PE Recurrence
  • Volume of blood aspirated
  • Use of thrombolytics
  • Change in Modified Miller Index
  • Quality of Life assessed via PEmb-QoL
  • Quality of Life assessed via EQ-5D-5L

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Pulmonary Embolism, Venous Thromboembolism, Cardiovascular Disease
  • Age: 18 years - 100 years
  • Gender: All

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 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 >45 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

Updated on 16 Mar 2026. Study ID: RADY-ARGON-CLEAN-PE, 27286

Interested in the study?

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