Thrombectomy System for Blood Clots in Lungs
(CLEAN-PE Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are using tPA (a clot-dissolving medication), you cannot have used it within 14 days before the trial's baseline assessment.
What data supports the effectiveness of the Cleaner Pro Thrombectomy System, Cleaner Vac Thrombectomy System, and Cleaner Pro Aspiration Thrombectomy System for treating blood clots in the lungs?
Is the thrombectomy system for blood clots in lungs generally safe for humans?
The AngioJet thrombectomy system, which is similar to the systems you mentioned, has been associated with some safety concerns, such as intravascular hemolysis (breakdown of red blood cells) that can lead to kidney injury. However, a study on the AngioVac system, another similar device, showed that it can be used safely, with some patients experiencing minor complications that resolved before discharge.678910
How is the Cleaner Pro Thrombectomy System treatment different from other treatments for blood clots in the lungs?
The Cleaner Pro Thrombectomy System is unique because it uses a mechanical approach to remove blood clots, which may offer an alternative to traditional drug-based therapies that dissolve clots. This system combines aspiration (suction) with a rotating wire to physically remove clots, potentially providing a faster and more controlled treatment option without the bleeding risks associated with clot-dissolving drugs.15111213
What is the purpose of this trial?
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Research Team
Pete J Stibbs, MD
Principal Investigator
Argon Medical Devices
Danyel C Carr, MS
Principal Investigator
Argon Medical Devices
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism using the Cleaner Pro Thrombectomy System
Initial Follow-up
Participants are monitored for safety and efficacy, including changes in RV/LV ratio and major adverse events, within 48 hours post-procedure
Extended Follow-up
Participants are monitored for symptomatic PE recurrence, device-related SAEs, all-cause mortality, and quality of life assessments at 30 days post-procedure
Treatment Details
Interventions
- Cleaner Pro Thrombectomy System
Cleaner Pro Thrombectomy System is already approved in United States for the following indications:
- Removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature
- Infusion of physician-specified fluids, including thrombolytics
Find a Clinic Near You
Who Is Running the Clinical Trial?
Argon Medical Devices
Lead Sponsor
NAMSA
Collaborator