Thrombectomy System for Blood Clots in Lungs

(CLEAN-PE Trial)

Recruiting at 19 trial locations

Overseen By Danyel C Carr, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Argon Medical Devices

Must not be taking: tPA, Anticoagulants

Disqualifiers: Pulmonary hypertension, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Immediate (procedure-based)

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Cleaner Pro Thrombectomy System to determine its safety and effectiveness in removing blood clots from the lungs in individuals with acute pulmonary embolism (PE). The goal is to assess whether this device can clear clots more effectively than current methods. Suitable participants have experienced sudden PE symptoms within the last 14 days and have confirmed clot blockage in their lungs. As an unphased trial, participants contribute to innovative research that could enhance treatment options for PE.

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 prior data suggests that the Cleaner Pro Thrombectomy System is safe for treating pulmonary embolism?

Research is examining the safety and effectiveness of the Cleaner Pro Thrombectomy System for treating blood clots in the lungs, known as pulmonary embolism (PE). The FDA has not yet approved the device for use in the lungs, but earlier animal studies suggested it is as safe as other devices used for similar treatments.

To date, no human studies have reported serious side effects directly caused by the Cleaner Pro System. However, as this treatment remains under investigation, further research is necessary to confirm its safety in people. Consulting a healthcare professional is important before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Cleaner Pro Thrombectomy System is unique because it offers a new approach to treating pulmonary embolism by mechanically removing blood clots from the lungs. Unlike standard treatments like anticoagulants, which help prevent further clotting but don't directly remove existing clots, this system uses catheter-directed therapy to physically extract the clots. Researchers are excited about this method because it has the potential to quickly restore blood flow, potentially reducing complications and improving recovery times for patients.

What evidence suggests that the Cleaner Pro Thrombectomy System is effective for pulmonary embolism?

Research has shown that the Cleaner Pro Thrombectomy System, which participants in this trial will receive, is designed to remove blood clots from the lungs, a condition known as pulmonary embolism (PE). This system uses a thin tube, called a catheter, to directly remove clots, potentially improving blood flow. Although the FDA has not yet approved this device for treating PE, it has shown promise in similar procedures for removing clots. Early studies suggested that this method could effectively clear blockages and restore normal blood flow in the lungs. However, more research is needed to confirm its safety and effectiveness specifically for treating PE. ^{1 2 3 4 5}

Who Is on the Research Team?

Danyel C Carr, MS

Principal Investigator

Argon Medical Devices

Pete J Stibbs, MD

Principal Investigator

Argon Medical Devices

Are You a Good Fit for This Trial?

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

RV dysfunction on CTA or echocardiography defined as RV/LV ratio >0.9

I am showing signs of a possible pulmonary embolism.

Filling defect in at least one main or lobar pulmonary artery evidenced by CTA

Exclusion Criteria

I have had a stroke or arterial blockage due to a clot traveling from veins to arteries.

Platelets <100,000/µL

History of heparin-induced thrombocytopenia (HIT)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism using the Cleaner Pro Thrombectomy System

Immediate (procedure-based)

1 visit (in-person)

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

48 hours

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

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Cleaner Pro Thrombectomy System

Trial Overview 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.

How Is the Trial Designed?

Group I: Mechanical Thrombectomy via Cleaner Pro Experimental Treatment 1 Intervention

Participants will receive catheter-directed therapy via mechanical aspiration thrombectomy for the treatment of pulmonary embolism (PE) using the Cleaner Pro Thrombectomy System.

Cleaner Pro Thrombectomy System is already approved in United States for the following indications:

Approved in United States as Cleaner Vac Thrombectomy System for:

• Removal of fresh, soft thrombi and emboli from the vessels of the peripheral venous vasculature
• Infusion of physician-specified fluids, including thrombolytics

Who Is Running the Clinical Trial?

Argon Medical Devices

Lead Sponsor

Trials

5

Recruited

1,600+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Published Research Related to This Trial

In an in vitro study comparing five embolectomy systems for clot removal, the Merci, CATCH, and Phenox Clot Retriever were found to be equally effective in mobilizing and removing thrombi, while the InTime and Attracter devices struggled to retrieve clots, often leading to fragmentation and displacement.

The Phenox Clot Retriever demonstrated a unique ability to filter out fragments during retrieval, highlighting the importance of a device's design in preventing distal embolization, which is crucial for effective treatment of thromboembolic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative in vitro study of five mechanical embolectomy systems: effectiveness of clot removal and risk of distal embolization. Liebig, T., Reinartz, J., Hannes, R., et al.[2022]

In the STRIDE study involving 119 patients with lower extremity acute limb ischemia, aspiration thrombectomy using the Indigo Aspiration System achieved a remarkable 98.2% limb salvage rate at 30 days, demonstrating its efficacy as a treatment option.

The procedure was found to be safe, with a low rate of major periprocedural bleeding (4.2%) and serious device-related adverse events (0.8%), indicating a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of mechanical aspiration thrombectomy at 30 days for patients with lower extremity acute limb ischemia. Maldonado, TS., Powell, A., Wendorff, H., et al.[2023]

The ReVive PV Peripheral Thrombectomy Device was successfully used in four patients (average age 68.8 years) to treat below-the-knee thromboembolic occlusions during proximal revascularization procedures, restoring blood flow without any complications.

This novel device shows promise for safely and effectively revascularizing distal arterial occlusions, which are critical for maintaining lower extremity blood flow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-man experience with the ReVive PV peripheral thrombectomy device for the revascularization of below-the-knee embolic occlusions. Landau, D., Moomey, C., Fiorella, D.[2014]

The use of a modified blower tool for thrombectomy on prosthetic mechanical valves has shown to effectively remove micro thrombus, leading to a completely cleaned valve.

This method offers advantages such as easier and more reliable thrombectomy with shorter cross-clamping times during surgery, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The blower: a useful tool to complete thrombectomy of the mechanical prosthetic valve. Aroussi, AA., Sami, IM., Leguerrier, A., et al.[2006]

The Rotarex mechanical thrombectomy system was found to be safe and effective in treating acute lower limb ischemia, with a success rate of 95.7% in a study of 23 patients, and a significant improvement in blood flow as indicated by the ankle-brachial index (ABI) increasing from 0.25 to 0.85 after treatment.

The procedure was minimally invasive, with a mean duration of 68.2 minutes and an average hospital stay of 3.6 days, making it a viable option for rapid restoration of blood flow in patients with acute ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of Rotarex mechanical thrombectomy system in acute lower limb ischemia]. Zhuang, JM., Li, TR., Li, X., et al.[2022]

In a study of 16 patients with acute iliofemoral deep vein thrombosis (DVT), the computer-aided mechanical aspiration thrombectomy (CMAT) using the Lightning 12 system achieved over 70% thrombus removal in all patients, demonstrating high efficacy in treating DVT.

The procedure was safe, with no patients requiring blood transfusions, and 93.8% of patients experienced symptom resolution before discharge, indicating a successful outcome with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device. Robertson, B., Neville, E., Muck, A., et al.[2022]

The aspiration thrombectomy system, featuring a 7-F Teflon catheter and a rotating coaxial propeller-tipped wire, successfully treated occlusions in two femoropopliteal arteries and one hemodialysis implant, indicating its efficacy in addressing vascular blockages.

Preliminary results suggest that mechanical thrombectomy could serve as a promising alternative to local lysis therapy, although it was not completely successful in one case involving a draining shunt vein.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration catheter for percutaneous thrombectomy: clinical results. Guenther, RW., Vorwerk, D.[2004]

A new mechanical thrombus aspiration system has been developed to enhance the speed and performance of thrombectomy procedures, which are commonly used in coronary and peripheral vascular treatments.

This novel system aims to combine the benefits of electromechanical systems, such as speed and power, with the ease-of-use and lower cost associated with basic syringe aspiration systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular innovations: Novel mechanical aspiration system to improve thrombus aspiration speed, force, and control. Fojtik, SP., Kronick, LS.[2022]

The rheolytic thrombectomy device, Hydrolyser, successfully removed 85% to 100% of thrombus from temporary vena cava filters in a controlled flow model, indicating its high efficacy for thrombus removal.

Despite the effective removal of thrombus, the procedure resulted in an embolization rate of 47% to 60%, highlighting the need for precautions to prevent potential complications from embolized particles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro evaluation of a rheolytic thrombectomy system for clot removal from five different temporary vena cava filters. Buecker, A., Neuerburg, J., Schmitz-Rode, T., et al.[2019]

A 45-year-old man developed severe acute kidney injury (AKI) due to heme pigment-induced damage following a thrombectomy using the AngioJet system, highlighting a rare but serious complication of this device.

Despite the initial need for dialysis, the patient's renal function fully recovered within five weeks, emphasizing the importance of recognizing and managing intravascular hemolysis in patients undergoing thrombectomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Report of Intravascular Hemolysis and Heme Pigment-Induced Nephropathy Following AngioJet Thrombectomy for Thrombosed DIPS Shunt. Tian, S., Sinclair, N., Shah, S.[2022]

The AngioJet Rapid Thrombectomy Catheter effectively removes thrombus during percutaneous coronary interventions, particularly in patients with saphenous vein bypass grafts, which can help reduce procedural complications.

The device operates using a Bernoulli effect-induced vacuum, highlighting its innovative mechanism for thrombus removal, although potential complications related to the procedure and device are also noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of thrombus containing lesions in diseased native coronary arteries and saphenous vein bypass grafts using the AngioJet Rapid Thrombectomy System. Hamburger, JN., Serruys, PW.[2019]

Early and comprehensive removal of thrombus in deep vein thrombosis can lead to better outcomes, such as reduced risk of post-thrombotic syndrome and long-term symptoms.

The Inari ClotTriever system, approved by the FDA in 2017, offers a safe and effective method for clot removal without the high bleeding risks associated with traditional thrombolytic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ClotTriever system for mechanical thrombectomy of deep vein thrombosis. Chan, SM., Laage Gaupp, FM., Mojibian, H.[2023]

Vacuum-assisted thrombectomy using the AngioVac System is a safe procedure for removing right heart thrombi, with 70-100% thrombus removal achieved in nearly 60% of patients and a low rate of serious complications, as all adverse events resolved before discharge.

In a study of 47 patients, the procedure had a short extracorporeal bypass time of less than 1 hour for most cases, and only one patient experienced a death unrelated to the procedure, highlighting its efficacy and safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Procedural outcomes associated with use of the AngioVac System for right heart thrombi: A safety report from RAPID registry data. Moriarty, JM., Liao, M., Kim, GHJ., et al.[2022]

Citations

1. argonmedical.com argonmedical.com/argon-medical-first-patient-enrollment-in-pulmonary-embolism-study/

Argon Medical Announces First Patient Enrollment in PE ... The CLEANER Vac Thrombectomy System is not currently cleared by the FDA for use in the pulmonary vasculature for treating of pulmonary embolism.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06189313

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

3. respiratory-therapy.com respiratory-therapy.com/disorders-diseases/cardiopulmonary-thoracic/pulmonary-embolism/trial-launches-test-novel-device-treating-pulmonary-embolism/

Trial Launches to Test Novel Device for Treating Pulmonary ... Argon Medical Devices has enrolled the first patient in a US-based study exploring a novel catheter-based device for managing blood clots in the lungs.

4. vascularnews.com vascularnews.com/argon-medical-enrols-first-patient-in-clean-pe-study/

Argon Medical enrols first patient in CLEAN-PE study The prospective, multicentre CLEAN-PE study aims to evaluate the safety and efficacy of the Cleaner Pro thrombectomy system.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K232679.pdf

January 19, 2024 Argon Medical Devices, Inc. Ana Jimenez ... The Cleaner Pro Thrombectomy System is a single use device in the removal of fresh, soft emboli and thrombi and for the infusion of physician-.