CLEANer Aspiration for Pulmonary Embolism
- Conditions
- Cardiovascular DiseasesPulmonary EmbolismVenous ThromboembolismAcute Pulmonary Embolism
- Interventions
- Device: Cleaner Pro Thrombectomy System
- Registration Number
- NCT06189313
- Lead Sponsor
- Argon Medical Devices
- Brief Summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mechanical Thrombectomy via Cleaner Pro Cleaner Pro Thrombectomy System Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
- Primary Outcome Measures
Name Time Method Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio At 48 hours post-procedure Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Rate of Major Adverse Events (MAEs) At 48 hours post-procedure Rate of MAEs within the first 48 hours after the index procedure, defined as:
Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury.
- Secondary Outcome Measures
Name Time Method Rate of device-related SAEs and all-cause mortality Within 30 days of procedure Rate of device-related serious adverse events (SAEs) and death for any cause within 30 days post-procedure.
Use of thrombolytics Within 48 hours of the procedure Use of thrombolytics within 48 hours of the procedure.
Rate of device-related complications and device-related death Within 48 hours of the procedure Rate of device-related complications including major bleeding, clinical deterioration, pulmonary vascular injury, and cardiac injury, and device-related death within 48 hours of the index procedure.
Rate of Symptomatic PE Recurrence Within 30 days of the procedure Rate of Symptomatic PE recurrence within 30 days.
Volume of blood aspirated At index procedure The amount of blood aspirated during the procedure.
Quality of Life assessed via PEmb-QoL At 30 days post-procedure Self-assessment of PE-related complaints and daily living limitations (including work and social). The PEmb-QoL measures 6 dimensions, with higher scores being worse.
Quality of Life assessed via EQ-5D-5L At 30 days post-procedure Self-assessment of activities for daily living. The EQ-5D-5L measures 5 dimensions, with higher scores being worse.
Change in Modified Miller Index At 48 hours post-procedure Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. This index score quantifies arterial obstruction in pulmonary embolism. The higher the score, the more perfusion is reduced.
Trial Locations
- Locations (8)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Medstar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Insight Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
UMass Chan Medical School
🇺🇸Worcester, Massachusetts, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Texas Heart Institute
🇺🇸Houston, Texas, United States