CLEANer Aspiration for Pulmonary Embolism

Description

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

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Study Overview

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Study Details

Study overview

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

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

CLEANer Aspiration for Pulmonary Embolism

Condition
Pulmonary Embolism
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Washington

Medstar Health Research Institute, Washington, District of Columbia, United States, 20010

Munster

Munster Medical Research/Community Hospital, Munster, Indiana, United States, 46321

Newark

Rutgers New Jersey Medical School, Newark, New Jersey, United States, 07102

Buffalo

University at Buffalo, Buffalo, New York, United States, 14203

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Dakota Dunes

Vascular and Interventional Specialists of Siouxland, Dakota Dunes, South Dakota, United States, 57049

Houston

Texas Heart Institute, Houston, Texas, United States, 77030

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-05-28