CLEANer Aspiration for Pulmonary Embolism (CLEAN-PE)

Argon Medical Devices

Status: Enrolling

Conditions: Venous Thromboembolism; Pulmonary Embolism; Acute Pulmonary Embolism; Cardiovascular Diseases

Treatments: Device: Cleaner Pro Thrombectomy System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06189313

CNPE01

Details and patient eligibility

About

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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125 participants in 1 patient group

Mechanical Thrombectomy via Cleaner Pro

Experimental group

Description:

Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.

Treatment:

Device: Cleaner Pro Thrombectomy System