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New catheter aims to clear Hard-to-Treat heart blockages
NCT ID NCT06795763
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called the Acolyte Catheter System in people with completely blocked heart arteries (chronic total occlusions) who still have symptoms despite medication. The goal is to see if the catheter can safely help doctors guide wires through the blockage to restore blood flow. About 115 adults will take part, and the study will track success rates and any serious heart events.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 115 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subject is \> 18 years of age at the time of consent * Subject is on medical therapy and continues to experience clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization * Female subjects of reproductive potential must have a negative pregnancy test per standard of care for PCI * Subject is willing and able to provided written informed consent * Subject is willing to and able to comply with the study protocol requirements including all follow up visits post-procedure Exclusion Criteria: * Subject has history of allergy to iodinated contrast that cannot be managed medically * Subject has evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment * Subject has had previous coronary interventional procedure of any kind within 30 days prior to the investigational procedure * Atherectomy procedure is planned for the target lesion * History of stroke or transient ischemic attack within 6 months prior to procedure * Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure * History of bleeding diathesis or coagulopathy or refusal of blood transfusions * Other pathology such as cancer, known mental illness, etc., or other condition which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study * Subject participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with this study's endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Emory University Hospital
Atlanta, Georgia, 30322, United States
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Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
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PharmaTex Research
Amarillo, Texas, 79106, United States
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Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
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St. Francis Hospital
Roslyn, New York, 11576, United States
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