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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Venous Thromboembolism; Pulmonary Embolism; Acute Pulmonary Embolism
• Intervention / Treatment: Device: Cleaner Pro Thrombectomy System

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Danyel C Carr, MS; Phone Number: 4697311421; Email: Clinical@argonmedical.com
• Study Contact Backup: Name: Holly Harrison; Phone Number: 4697313561

Study Locations

• United States
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
      • Vascular and Interventional Specialists of Siouxland
      • Contact: Nikolas Arvis, MD; Phone Number: 605-217-7751
      • Principal Investigator: Neal Khurana, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mechanical Thrombectomy via Cleaner Pro; Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.	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.; Other Names: Cleaner Vac Thrombectomy System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Use of thrombolytics	Use of thrombolytics within 48 hours of the procedure.	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.	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.	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.	At 30 days post-procedure
Rate of Symptomatic PE Recurrence	Rate of Symptomatic PE recurrence within 30 days.	Within 30 days of the procedure
Volume of blood aspirated	The amount of blood aspirated during the procedure.	At index procedure

Collaborators and Investigators

• Sponsor: Argon Medical Devices
• Collaborators: NAMSA
• Investigators: Study Director: Danyel C Carr, MS, Argon Medical Devices; Study Director: Pete J Stibbs, MD, Argon Medical Devices; Principal Investigator: Aravinda Nanjundappa, MD, The Cleveland Clinic; Principal Investigator: Neal Khurana, MD, Vascular and Interventional Specialists of Siouxland

Study record dates

Study Major Dates

• Study Start (Estimated): May 23, 2024
• Primary Completion (Estimated): May 18, 2025
• Study Completion (Estimated): June 24, 2025

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PE; pulmonary embolism; aspiration thrombectomy; catheter directed thrombectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Cardiovascular Diseases; Embolism; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: CNPE01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes