All-in-One stent aims to prevent strokes during artery procedure

NCT ID NCT05845710

Completed Disease control Sponsor: Contego Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device that combines a stent, a filter to catch debris, and a balloon in one system for treating narrowed carotid arteries. It involved 178 patients at high risk for standard surgery. The main goal was to see if the device reduces the chance of stroke, heart attack, or death within 30 days.

What this could mean

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

Active substance: Neuroguard IEP Direct System (a carotid stent with an integrated embolic filter and post-dilation balloon)
What this could lead to: If successful, this device could offer a safer way to open blocked carotid arteries in patients who are too high-risk for traditional surgery, potentially reducing stroke risk.
What could go wrong: This is a single-arm study with no comparison group, so results may not prove superiority over existing treatments. The device is new, and long-term safety data are not yet available.

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.

carotid artery disorder carotid stenosis

As listed by the trial registrant

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

CAROTID ARTERY DISEASES CAROTID STENOSIS

Contacts and locations

Locations

AdventHealth Orlando

Orlando, Florida, 32803, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Atrium Health - Sanger Heart and Vascular

Charlotte, North Carolina, 28204, United States
Baylor Scott and White Research Institute

Dallas, Texas, 75246, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Delray Medical Center

Delray Beach, Florida, 33484, United States
GH Paris St. Joseph

Paris, 75014, France
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Honor Health

Scottsdale, Arizona, 85258, United States
Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France
Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States
Manatee Memorial Hospital

Bradenton, Florida, 34208, United States
McLaren Center for Research and Innovation

Bay City, Michigan, 48708, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Mount Sinai Medical Center

New York, New York, 10029, United States
Mount Sinai Vascular Institute

Miami Beach, Florida, 33140, United States
North Carolina Heart and Vascular Research

Raleigh, North Carolina, 27607, United States
Northwell Health

Lake Success, New York, 11042, United States
OhioHealth Research Institute

Columbus, Ohio, 43214, United States
Prisma Health

Greenville, South Carolina, 29615, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Sisters of Charity Hospital

Buffalo, New York, 14214, United States
Southcoast Health

New Bedford, Massachusetts, 02720, United States
St. David's Healthcare

Austin, Texas, 78756, United States
St. Francis Hospital

Tulsa, Oklahoma, 74136, United States
TriHealth (Bethesda North Hospital)

Cincinnati, Ohio, 45242, United States
UNC Hospital

Chapel Hill, North Carolina, 27514, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
University at Buffalo Neurosurgery - Jacobs Institute

Buffalo, New York, 14203, United States
Vanderbilt University

Nashville, Tennessee, 37232-5545, United States

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