NOT_YET_RECRUITING
CLEANer Aspiration for Pulmonary Embolism
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Conditions:
🦠 Pulmonary Embolism 🦠 Acute Pulmonary Embolism 🦠 Cardiovascular Diseases 🦠 Venous Thromboembolism
🗓️ Study Start (Actual) 22 July 2024
🗓️ Primary Completion (Estimated) 14 July 2025
✅ Study Completion (Estimated) 20 August 2025
👥 Enrollment (Estimated) 125
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Washington, District of Columbia, United States
📍 Newark, New Jersey, United States
📍 Dakota Dunes, South Dakota, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 December 2023
  • First Submitted that Met QC Criteria 19 December 2023
  • First Posted 3 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 June 2024
  • Last Update Posted 6 June 2024
  • Last Verified June 2024