CLEANer Aspiration for Pulmonary Embolism

Launched by ARGON MEDICAL DEVICES · Dec 19, 2023

Keywords

ClinConnect Summary

The CLEANer trial is studying a new device called the Cleaner™ Pro Thrombectomy System, which is designed to help remove blood clots from the lungs in patients with acute pulmonary embolism (PE). This condition occurs when a blood clot blocks blood flow to the lungs, which can be very serious. The trial aims to see how safe and effective this device is for treating patients who show signs of PE and have experienced symptoms within the last 14 days.

To participate in the trial, individuals must be at least 18 years old and have specific signs of PE, such as certain imaging results showing a blockage in the lungs. However, there are several health conditions and recent medical treatments that may exclude someone from joining, like having low blood pressure or a history of severe bleeding. If eligible, participants will have the opportunity to receive this new treatment and help researchers learn more about its effectiveness for future patients.

Gender

ALL

Eligibility criteria

• 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 \>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