CLEANer Aspiration for Pulmonary Embolism

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Medstar Health Research Institute
Washington, District of Columbia 20010
Contact:
Suman Singh
suman.singh@medstar.net

More Details

Status
Recruiting
Sponsor
Argon Medical Devices

Study Contact

Danyel C Carr, MS
4697311421
Clinical@argonmedical.com