Using a device to remove blood clots in patients with pulmonary embolism
A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
This study is testing a new device to see if it can safely remove blood clots from the lungs in people with pulmonary embolism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Argon Medical Devices Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Aurora, Colorado and 7 other locations) |
| Trial ID | NCT06189313 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the Cleaner™ Pro Thrombectomy System for performing aspiration thrombectomy in patients diagnosed with acute pulmonary embolism (PE). Participants must show clinical signs of PE and have specific imaging results indicating a filling defect in their pulmonary arteries. The study aims to determine if this innovative device can improve patient outcomes by effectively removing blood clots from the lungs. The trial will include patients who meet the eligibility criteria and will be conducted at multiple medical centers.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with acute pulmonary embolism symptoms and meet specific imaging and clinical criteria.
Not a fit: Patients with severe pulmonary hypertension or those requiring high levels of oxygen support may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the treatment of acute pulmonary embolism, potentially reducing mortality and morbidity associated with the condition.
How similar studies have performed: Other studies have explored similar thrombectomy techniques, showing promising results, but this specific device's efficacy is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado and 7 other locations
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
- Medstar Health Research Institute — Washington, District of Columbia, United States (Recruiting)
- Insight Hospital and Medical Center — Chicago, Illinois, United States (Recruiting)
- UMass Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
- Rutgers New Jersey Medical School — Newark, New Jersey, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Texas Heart Institute — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Danyel C Carr, MS
- Email: Clinical@argonmedical.com
- Phone: 4697311421
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.