New Stent-Like device aims to adapt to heart arteries
NCT ID NCT05464147
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
Researchers are testing a stent-like device called the DynamX Drug-Eluting Coronary Bioadaptor System in people with complex coronary artery blockages, including long lesions, chronic total occlusions, and blockages at artery branches. The study enrolls about 55 adults and measures how well the device keeps the artery open and how the vessel responds over 9 months using optical coherence tomography imaging. The goal is to see whether this device performs well in these difficult-to-treat lesions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DynamX Drug-Eluting Coronary Bioadaptor System, a stent-like device that releases medication and is designed to adapt to the artery
- What this could lead to
- If it works, this could offer a new option for people with complex coronary blockages that are hard to treat with standard stents.
- What could go wrong
- This is a small, early study with no control group, so it cannot prove the device works better than existing stents. Risks include those of any coronary procedure, such as bleeding, infection, or heart attack.
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
-
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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55 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Aug 2025
- 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
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
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: Presence of complex coronary lesions defined as follows: * long lesions (\>28 mm); * CTO, a total occlusion of duration more than 3-months; * Lesions involving a bifurcation, defined as a division with a side branch large enough to be stented (i.e. \>2.25 mm); * Patients requiring 4 or more stents * Reference vessel diameter: \>2.25 mm to \<4.0 mm Exclusion Criteria: * Age under 18 years old; * Significant co-morbidity precluding clinical follow-up; * A positive pregnancy test in women with child-bearing potential; * Contra-indication to dual anti-platelet therapy; * Thrombocytopenia \<100,000/uL; * Major surgery planned which will lead to discontinuation of antiplatelet therapy; * In-stent restenosis; * Treatment of saphenous vein graft; * CTO with long sub-intimal tracking (\> 20 mm).
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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
Locations
-
Humanitas Research Hospital
Rozzano, Italy
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Other studies related to the condition(s) this trial covers.
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