CLEAN-PE: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism

Primary Objective

Evaluate the safety and efficacy of the Cleanerâ„¢ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

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Description

Prospective, single-arm, multicenter study. Approximately 125 subjects will be screened for 105 enrolled at up to 15 investigational sites in the United States.

Details
Age
Adult
Eligibility
1. At least 18 years of age at the time of consent. 2. Clinical signs, symptoms, and presentation consistent with acute PE. 3. Onset of PE symptoms occurred within 14 days of presentation. 4. Filling defect in at least one main or lobar pulmonary artery evidenced by CTA. 5. RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9.
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Robert Ryu

Robert Ryu

Study ID

Protocol Number: 24-0526

More information available at ClinicalTrials.gov: NCT06189313

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