Drug-Coated balloon shows promise for clogged heart arteries in 2-Year study
NCT ID NCT07415902
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study reviews medical records of 252 patients who received a drug-coated balloon to treat blocked heart arteries. The goal is to see how safe and effective the balloon is over two years. Researchers will track heart-related deaths, heart attacks, and the need for repeat procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- drug-coated balloon catheter
- What this could lead to
- If successful, this could confirm that drug-coated balloons are a safe and effective long-term option for treating blocked heart arteries, potentially reducing the need for more stents.
- What could go wrong
- This is a retrospective study, meaning it looks back at past data, not a controlled experiment. Results may be less reliable, and the balloon may not work for all types of blockages.
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.
- Participants
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About 252 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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.
Who is studied
This study will retrospectively enroll all eligible subjects aged 18 years and above with in-stent restenosis or de novo coronary artery lesions.
- 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: * Age: ≥18 years old, regardless of gender; * Presence of symptomatic coronary heart disease or objective clinical evidence of myocardial ischemia; * Treated with DCB for one of the following lesions: in-stent restenosis (any stent type) or de novo lesions with a reference vessel diameter of ≥2.0 mm and ≤2.75 mm. Exclusion Criteria: * Residual stenosis \>30% after pre-treatment with type C or higher dissection; * A history of cardiogenic shock; * Severe congestive heart failure or NYHA class IV severe heart failure; * Pregnant or lactating women; * Life expectancy ≤24 months (e.g., patients with extensive metastatic malignant tumors).
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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
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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