Pulmonary EmbolismCLEAN-PENCT06189313
CLEANer Aspiration for Pulmonary Embolism
A study testing Cleaner Pro Thrombectomy System in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Argon Medical Devices at 14 sites in United States.
Trial summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Acute Pulmonary Embolism, Cardiovascular Diseases
- What is being tested?
- Cleaner Pro Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 14 sitesUnited States
- Study dates
- 3 Jan 2025to 2 Feb 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 26Show fewer
- 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 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 locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Ascension St. John Jane Phillips Medical Center
Bartlesville, Oklahoma, 74006
University of Cincinnati
Cincinnati, Ohio, 45267
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor Scott and White Heart and Vascular Hospital - Dallas
Dallas, Texas, 75226
Janna, LLC
Fort Lauderdale, Florida, 33316
Vital Heart and Vein
Humble, Texas, 77338
Ascension St. Vincent Hospital
Indianapolis, Indiana, 46260
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Baylor Scott & White The Heart Hospital - Plano
Plano, Texas, 75093
BayCare Health System
Tampa, Florida, 33607
Promedica Toledo Hospital
Toledo, Ohio, 43606
Medstar Health Research Institute
Washington D.C., District of Columbia, 20010
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism, Cardiovascular Diseases, Venous Thromboembolism
- Being tested
- Cleaner Pro Thrombectomy System
- Keywords
- pulmonary embolism, aspiration thrombectomy, PE, catheter directed thrombectomy
- Medical subject headings
- Pulmonary Embolism, Cardiovascular Diseases, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleaner Pro Thrombectomy SystemDevice
Also called Cleaner Vac Thrombectomy System
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.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Thrombectomy via Cleaner Pro | Experimental | Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System. Receives: Device: Cleaner Pro Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Measured: 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.
Measured: At 48 hours post-procedure
Secondary outcomes (8)
Rate of device-related complications and device-related death
Rate of device-related complications including major bleeding, clinical deterioration, pulmonary vascular injury, and cardiac injury, and device-related death within 48 hours of the index procedure.
Measured: Within 48 hours of the procedure
Rate of device-related SAEs and all-cause mortality
Rate of device-related serious adverse events (SAEs) and death for any cause within 30 days post-procedure.
Measured: Within 30 days of procedure
Rate of Symptomatic PE Recurrence
Rate of Symptomatic PE recurrence within 30 days.
Measured: Within 30 days of the procedure
Volume of blood aspirated
The amount of blood aspirated during the procedure.
Measured: At index procedure
Use of thrombolytics
Use of thrombolytics within 48 hours of the procedure.
Measured: Within 48 hours of the procedure
Change in Modified Miller Index
Change in Modified Miller Index between baseline and 48 hours post-procedure assessed by CTA. This index score quantifies arterial obstruction in pulmonary embolism. The higher the score, the more perfusion is reduced.
Measured: At 48 hours post-procedure
Quality of Life assessed via PEmb-QoL
Self-assessment of PE-related complaints and daily living limitations (including work and social). The PEmb-QoL measures 6 dimensions, with higher scores being worse.
Measured: At 30 days post-procedure
Quality of Life assessed via EQ-5D-5L
Self-assessment of activities for daily living. The EQ-5D-5L measures 5 dimensions, with higher scores being worse.
Measured: At 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Jan 2025
- Primary completion4 Nov 2028 (estimated)
- Study completion2 Feb 2029 (estimated)
Why it stopped: Enrollment in the study administratively paused pending modifications to the study device design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Argon Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Pete J Stibbs, MD, Study director, Argon Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189313
- Sponsor's protocol ID
- CNPE01
- Acronym
- CLEAN-PE
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Safety and Efficacy of an Aspiration Thrombectomy System in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06189313
- Acronym / sponsor ID
- CLEAN-PE / CNPE01
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism, Cardiovascular Diseases, Venous Thromboembolism
- Keywords
- pulmonary embolism, aspiration thrombectomy, PE, catheter directed thrombectomy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Enrollment in the study administratively paused pending modifications to the study device design
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Argon Medical DevicesIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 4 Nov 2028 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Thrombectomy via Cleaner Pro | Experimental | Device: Cleaner Pro Thrombectomy SystemParticipants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (26 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleaner Pro Thrombectomy SystemAlso: Cleaner Vac Thrombectomy SystemThe 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. | Device | Mechanical Thrombectomy via Cleaner Pro |
Primary outcome
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Time frame: At 48 hours post-procedure
Change in RV/LV ratio between baseline and 48 hours post procedure assessed by CTA.
Rate of Major Adverse Events (MAEs)
Time frame: At 48 hours post-procedure
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.
8 secondary outcomes
Rate of device-related complications and device-related death
Time frame: Within 48 hours of the procedure
Rate of device-related SAEs and all-cause mortality
Time frame: Within 30 days of procedure
Rate of Symptomatic PE Recurrence
Time frame: Within 30 days of the procedure
Volume of blood aspirated
Time frame: At index procedure
Use of thrombolytics
Time frame: Within 48 hours of the procedure
Change in Modified Miller Index
Time frame: At 48 hours post-procedure
Quality of Life assessed via PEmb-QoL
Time frame: At 30 days post-procedure
Quality of Life assessed via EQ-5D-5L
Time frame: At 30 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pete J Stibbs, MD study director
Argon Medical Devices
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleaner Pro Thrombectomy System in people with Pulmonary Embolism and Acute Pulmonary Embolism, run by Argon Medical Devices at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio (time frame: At 48 hours post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.