CLEANer Aspiration for Pulmonary Embolism
CLEAN-PE
A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
1 other identifier
interventional
125
1 country
14
Brief Summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2023
CompletedFirst Posted
Study publicly available on registry
January 3, 2024
CompletedStudy Start
First participant enrolled
January 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 2, 2027
March 12, 2026
March 1, 2026
2.4 years
December 19, 2023
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
At 48 hours post-procedure
Rate of Major Adverse Events (MAEs)
Rate of MAEs within the first 48 hours after the index procedure, defined as: Device-related death Major bleeding, and Device-related Serious Adverse Events which includes clinical deterioration, pulmonary vascular injury, and cardiac injury.
At 48 hours post-procedure
Secondary Outcomes (8)
Rate of device-related complications and device-related death
Within 48 hours of the procedure
Rate of device-related SAEs and all-cause mortality
Within 30 days of procedure
Rate of Symptomatic PE Recurrence
Within 30 days of the procedure
Volume of blood aspirated
At index procedure
Use of thrombolytics
Within 48 hours of the procedure
- +3 more secondary outcomes
Study Arms (1)
Mechanical Thrombectomy via Cleaner Pro
EXPERIMENTALParticipants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
Interventions
The Cleaner™ Pro Thrombectomy System ("Cleaner Pro") is a catheter-based aspiration thrombectomy device comprised of a handpiece, an aspiration catheter, a dilator, and an aspiration canister.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Argon Medical Deviceslead
- NAMSAcollaborator
Study Sites (14)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
Ascension Sacred Heart Hospital
Pensacola, Florida, 32504, United States
BayCare Health System
Tampa, Florida, 33607, United States
Insight Hospital and Medical Center
Chicago, Illinois, 60616, United States
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
UMass Chan Medical School
Worcester, Massachusetts, 01655, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Promedica Toledo Hospital
Toledo, Ohio, 43606, United States
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma, 74006, United States
Baylor Scott and White Heart and Vascular Hospital - Dallas
Dallas, Texas, 75226, United States
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Danyel C Carr, MS
Argon Medical Devices
- STUDY DIRECTOR
Pete J Stibbs, MD
Argon Medical Devices
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2023
First Posted
January 3, 2024
Study Start
January 3, 2025
Primary Completion (Estimated)
June 4, 2027
Study Completion (Estimated)
September 2, 2027
Last Updated
March 12, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share