New Clot-Busting catheter shows promise for lung blood clots

NCT ID NCT05597891

Completed Disease control Sponsor: Endovascular Engineering Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called the Hēlo PE Thrombectomy System, which is a thin tube used to remove blood clots from the lungs in people with a serious condition called pulmonary embolism. The trial included 177 participants and aimed to see if the device is safe and works well. The main goal was to reduce the strain on the heart caused by the clot, measured by a heart imaging test, within 48 hours of the procedure.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Hēlo PE Thrombectomy System (a catheter device used to remove blood clots from the lungs)
What this could lead to: If this device works well, it could offer a new, less invasive way to quickly remove dangerous blood clots from the lungs, potentially reducing complications and improving recovery for people with pulmonary embolism.
What could go wrong: This is an early feasibility study with no comparison group, so results may not prove the device is better than standard treatments. There are also risks of bleeding, vessel injury, or other serious complications during the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PULMONARY EMBOLISM

Contacts and locations

Locations

Austin Heart

Austin, Texas, 78705, United States
Baptist Health Research Institute

Jacksonville, Florida, 32207, United States
Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States
Delray Medical Center

Delray Beach, Florida, 33484, United States
Gundersen Health

La Crosse, Wisconsin, 54601, United States
HCA Florida Memorial Hospital

Jacksonville, Florida, 32216, United States
Huntington Hospital

Pasadena, California, 91105, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
PIH Health Good Samaritan Hospital

Los Angeles, California, 90017, United States
Piedmont Heart

Atlanta, Georgia, 30309, United States
Temple University

Philadelphia, Pennsylvania, 19122, United States
Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States
Torrance Memorial Medical Center

Torrance, California, 90505, United States
TriHealth Hatton Research Institute

Cincinnati, Ohio, 45242, United States
UT Health

Houston, Texas, 77030, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Wellmont Cardiology Services / Ballad Health

Kingsport, Tennessee, 37660, United States

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