← Back to Search

Thrombectomy Device

Mechanical Thrombectomy via Cleaner Pro for Cardiovascular Disease (CLEAN-PE Trial)

N/A

Waitlist Available

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

CLEAN-PE Trial 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.Check my eligibility

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.See study design

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.

CLEAN-PE Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 hours post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Right Ventricle (RV)/Left Ventricle (LV) Ratio

Rate of Major Adverse Events (MAEs)

Secondary outcome measures

Change in Modified Miller Index

Quality of Life assessed via EQ-5D-5L

Quality of Life assessed via PEmb-QoL

+5 more

CLEAN-PE 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NAMSAOTHER

46 Previous Clinical Trials

18,707 Total Patients Enrolled

Argon Medical DevicesLead Sponsor

3 Previous Clinical Trials

1,431 Total Patients Enrolled

Pete J Stibbs, MDStudy DirectorArgon Medical Devices

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"As per the details on clinicaltrials.gov, recruitment for this particular trial is currently closed. The study was first listed on May 23rd, 2024, and last updated on April 8th, 2024. While this specific research project is not actively seeking participants, there are a substantial number of 624 alternative studies that are presently open for enrollment."

Answered by AI

What is the main objective of this medical study?

"Argon Medical Devices, the sponsor of this trial, has identified the primary outcome as the Rate of Major Adverse Events (MAEs), to be assessed 48 hours post-procedure. Secondary outcomes include Volume of blood aspirated - signifying the quantity drawn during intervention; Change in Modified Miller Index - gauging arterial obstruction alterations between baseline and post-intervention through CTA assessment; and Rate of Symptomatic PE Recurrence within a 30-day period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CLEANer Aspiration for Pulmonary Embolism

2024. "CLEANer Aspiration for Pulmonary Embolism". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06189313.

All > Pulmonary Embolism