CLEANer Aspiration for Pulmonary Embolism (NCT06189313) | Clinical Trial Compass
SuspendedNot Applicable
CLEANer Aspiration for Pulmonary Embolism
Stopped: Enrollment in the study administratively paused pending modifications to the study device design
United States125 participantsStarted 2025-01-03
Plain-language summary
To evaluate the safety and efficacy of the Cleanerâ„¢ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion.
* 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
* Presence of intracardiac lead in the right ventricle or…
What they're measuring
1
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio