RECRUITING

CLEANer Aspiration for Pulmonary Embolism

Conditions

Pulmonary Embolism Acute Pulmonary Embolism Cardiovascular Diseases Venous Thromboembolism aspiration thrombectomy PE catheter directed thrombectomy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-10

Study Completion:2026-05-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06189313

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Danyel C Carr, MS

CONTACT

4697311421

Clinical@argonmedical.com

Holly Harrison

CONTACT

4697313561

Principal Investigator

Danyel C Carr, MS

STUDY_DIRECTOR

Argon Medical Devices

Pete J Stibbs, MD

STUDY_DIRECTOR

Argon Medical Devices

Aravinda Nanjundappa, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Neal Khurana, MD

PRINCIPAL_INVESTIGATOR

Vascular and Interventional Specialists of Siouxland

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Medstar Health Research Institute

Washington, District of Columbia, 20010

United States

Munster Medical Research/Community Hospital

Munster, Indiana, 46321

United States

Rutgers New Jersey Medical School

Newark, New Jersey, 07102

United States

University at Buffalo

Buffalo, New York, 14203

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Vascular and Interventional Specialists of Siouxland

Dakota Dunes, South Dakota, 57049

United States

Texas Heart Institute

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Argon Medical Devices

Danyel C Carr, MS, STUDY_DIRECTOR, Argon Medical Devices
Pete J Stibbs, MD, STUDY_DIRECTOR, Argon Medical Devices
Aravinda Nanjundappa, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic
Neal Khurana, MD, PRINCIPAL_INVESTIGATOR, Vascular and Interventional Specialists of Siouxland

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10

Study Completion Date2026-05-28

Study Record Updates

Study Start Date2024-10

Study Completion Date2026-05-28

Terms related to this study

Keywords Provided by Researchers

pulmonary embolism
aspiration thrombectomy
PE
catheter directed thrombectomy

Additional Relevant MeSH Terms

Pulmonary Embolism
Acute Pulmonary Embolism
Cardiovascular Diseases
Venous Thromboembolism