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Thrombectomy Device
Thrombectomy System for Blood Clots in Lungs (CLEAN-PE Trial)
N/A
Recruiting
Led By Aravinda Nanjundappa, MD
Research Sponsored by Argon Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 48 hours post-procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how safe and effective the Cleaner™ Pro Thrombectomy System is for removing blood clots in the lungs of patients with acute pulmonary embolism.
Who is the study for?
This trial is for adults over 18 with recent symptoms of acute pulmonary embolism (PE), which is a blood clot in the lungs. Participants must have signs of right ventricular dysfunction and a visible clot in at least one main lung artery on imaging tests.
What is being tested?
The Cleaner Pro Thrombectomy System, a device designed to remove clots from blood vessels, is being tested for its safety and effectiveness in treating patients with acute pulmonary embolism.
What are the potential side effects?
Potential side effects may include bleeding, damage to blood vessels where the device is used, irregular heartbeats, or other complications related to the procedure or device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 48 hours post-procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 48 hours post-procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio
Rate of Major Adverse Events (MAEs)
Secondary study objectives
Change in Modified Miller Index
Quality of Life assessed via EQ-5D-5L
Quality of Life assessed via PEmb-QoL
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Mechanical Thrombectomy via Cleaner ProExperimental Treatment1 Intervention
Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.
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Who is running the clinical trial?
NAMSAOTHER
53 Previous Clinical Trials
20,888 Total Patients Enrolled
Argon Medical DevicesLead Sponsor
3 Previous Clinical Trials
1,431 Total Patients Enrolled
Pete J Stibbs, MDStudy DirectorArgon Medical Devices
Aravinda Nanjundappa, MDPrincipal InvestigatorThe Cleveland Clinic
Neal Khurana, MDPrincipal InvestigatorVascular and Interventional Specialists of Siouxland
Danyel C Carr, MSStudy DirectorArgon Medical Devices
1 Previous Clinical Trials
3 Total Patients Enrolled