CLEANer Aspiration for Pulmonary Embolism

Cardiovascular Diseases Clinical Trial

— CLEAN-PE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06189313
• Other study ID #: CNPE01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: June 24, 2025

Study information

• Verified date: April 2024
• Source: Argon Medical Devices
• Contact: Danyel C Carr, MS
• Phone: 4697311421
• Email: Clinical[@]argonmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: June 24, 2025
• Est. primary completion date: May 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 >45 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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Cardiovascular Diseases
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Venous Thromboembolism

Intervention

Device:
• Cleaner Pro 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.

Locations

Country	Name	City	State
United States	Vascular and Interventional Specialists of Siouxland	Dakota Dunes	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Argon Medical Devices	NAMSA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Within 48 hours of the procedure
Secondary	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.	Within 30 days of procedure
Secondary	Rate of Symptomatic PE Recurrence	Rate of Symptomatic PE recurrence within 30 days.	Within 30 days of the procedure
Secondary	Volume of blood aspirated	The amount of blood aspirated during the procedure.	At index procedure
Secondary	Use of thrombolytics	Use of thrombolytics within 48 hours of the procedure.	Within 48 hours of the procedure
Secondary	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.	At 48 hours post-procedure
Secondary	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.	At 30 days post-procedure
Secondary	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.	At 30 days post-procedure