Clinical trial NCT06189313: CLEANer Aspiration for Pulmonary Embolism
Official title: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Acute Pulmonary Embolism
Cardiovascular Diseases
Venous Thromboembolism
Keywords: pulmonary embolism
aspiration thrombectomy
PE
catheter directed thrombectomy
Lead sponsor: Argon Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2024-01-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
timeFrame: At 48 hours post-procedure
measure: Rate of Major Adverse Events (MAEs)
timeFrame: At 48 hours post-procedure
Secondary outcomes:
measure: Rate of device-related complications and device-related death
timeFrame: Within 48 hours of the procedure
measure: Rate of device-related SAEs and all-cause mortality
timeFrame: Within 30 days of procedure
measure: Rate of Symptomatic PE Recurrence
timeFrame: Within 30 days of the procedure
measure: Volume of blood aspirated
timeFrame: At index procedure
measure: Use of thrombolytics
timeFrame: Within 48 hours of the procedure
measure: Change in Modified Miller Index
timeFrame: At 48 hours post-procedure
measure: Quality of Life assessed via PEmb-QoL
timeFrame: At 30 days post-procedure
measure: Quality of Life assessed via EQ-5D-5L
timeFrame: At 30 days post-procedure
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Medstar Health Research Institute
state: District of Columbia
city: Chicago
country: United States
facility: Insight Hospital and Medical Center
state: Illinois
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
Study officials:
affiliation: Argon Medical Devices
name: Danyel C Carr, MS
role: STUDY_DIRECTOR
affiliation: Argon Medical Devices
name: Pete J Stibbs, MD
role: STUDY_DIRECTOR
References: