All-in-One stent aims to prevent strokes during artery procedure
NCT ID NCT05845710
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.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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AdventHealth Orlando
Orlando, Florida, 32803, United States
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Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
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Atrium Health - Sanger Heart and Vascular
Charlotte, North Carolina, 28204, United States
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Baylor Scott and White Research Institute
Dallas, Texas, 75246, United States
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Cleveland Clinic
Cleveland, Ohio, 44195, United States
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Delray Medical Center
Delray Beach, Florida, 33484, United States
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GH Paris St. Joseph
Paris, 75014, France
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Hartford Hospital
Hartford, Connecticut, 06102, United States
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Honor Health
Scottsdale, Arizona, 85258, United States
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Hopital Marie Lannelongue
Le Plessis-Robinson, 92350, France
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Indiana University Methodist Hospital
Indianapolis, Indiana, 46202, United States
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Manatee Memorial Hospital
Bradenton, Florida, 34208, United States
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McLaren Center for Research and Innovation
Bay City, Michigan, 48708, United States
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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Mount Sinai Medical Center
New York, New York, 10029, United States
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Mount Sinai Vascular Institute
Miami Beach, Florida, 33140, United States
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North Carolina Heart and Vascular Research
Raleigh, North Carolina, 27607, United States
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Northwell Health
Lake Success, New York, 11042, United States
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OhioHealth Research Institute
Columbus, Ohio, 43214, United States
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Prisma Health
Greenville, South Carolina, 29615, United States
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Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
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Sisters of Charity Hospital
Buffalo, New York, 14214, United States
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Southcoast Health
New Bedford, Massachusetts, 02720, United States
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St. David's Healthcare
Austin, Texas, 78756, United States
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St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
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TriHealth (Bethesda North Hospital)
Cincinnati, Ohio, 45242, United States
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UNC Hospital
Chapel Hill, North Carolina, 27514, United States
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UT Southwestern Medical Center
Dallas, Texas, 75390, United States
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University at Buffalo Neurosurgery - Jacobs Institute
Buffalo, New York, 14203, United States
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Vanderbilt University
Nashville, Tennessee, 37232-5545, United States