CLEANer Aspiration for Pulmonary Embolism
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mechanical Thrombectomy via Cleaner Pro |
Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System. |
|
Recruiting Locations
Medstar Health Research Institute
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- Argon Medical Devices