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

Enrolling By Invitation
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 28 Jul 2025. Study ID: RADY-ARGON-CLEAN-PE, 27286
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only