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

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

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 more

Awards & 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.

Do I qualify?Apply below to find out