125 Participants Needed

Thrombectomy System for Blood Clots in Lungs

(CLEAN-PE Trial)

Recruiting at 9 trial locations
HH
DC
Overseen ByDanyel C Carr, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Argon Medical Devices
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research on similar aspiration thrombectomy systems shows they can successfully remove blood clots in other parts of the body, like the legs, without needing additional clot-dissolving drugs. This suggests that the Cleaner systems might also be effective for clots in the lungs.12345

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

PJ

Pete J Stibbs, MD

Principal Investigator

Argon Medical Devices

DC

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

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
See 1 more

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)
See 24 more

Timeline

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

Treatment Details

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.
Participant Groups
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.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Argon Medical Devices

Lead Sponsor

Trials
5
Recruited
1,600+

NAMSA

Collaborator

Trials
55
Recruited
21,500+

Findings from Research

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

References

Aspiration catheter for percutaneous thrombectomy: clinical results. [2004]
First-in-man experience with the ReVive PV peripheral thrombectomy device for the revascularization of below-the-knee embolic occlusions. [2014]
Comparative in vitro study of five mechanical embolectomy systems: effectiveness of clot removal and risk of distal embolization. [2022]
Technical success and short-term results from mechanical thrombectomy for lower extremity iliofemoral deep vein thrombosis using a computer aided mechanical aspiration thrombectomy device. [2022]
Cardiovascular innovations: Novel mechanical aspiration system to improve thrombus aspiration speed, force, and control. [2022]
[Application of Rotarex mechanical thrombectomy system in acute lower limb ischemia]. [2022]
Safety and efficacy of mechanical aspiration thrombectomy at 30 days for patients with lower extremity acute limb ischemia. [2023]
Treatment of thrombus containing lesions in diseased native coronary arteries and saphenous vein bypass grafts using the AngioJet Rapid Thrombectomy System. [2019]
A Case Report of Intravascular Hemolysis and Heme Pigment-Induced Nephropathy Following AngioJet Thrombectomy for Thrombosed DIPS Shunt. [2022]
Procedural outcomes associated with use of the AngioVac System for right heart thrombi: A safety report from RAPID registry data. [2022]
The blower: a useful tool to complete thrombectomy of the mechanical prosthetic valve. [2006]
12.United Statespubmed.ncbi.nlm.nih.gov
In vitro evaluation of a rheolytic thrombectomy system for clot removal from five different temporary vena cava filters. [2019]
ClotTriever system for mechanical thrombectomy of deep vein thrombosis. [2023]
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