New study tests which balloon best heals heart arteries after a heart attack
NCT ID NCT07514988
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of drug-coated balloons used to open blocked heart arteries in people with acute coronary syndrome (a serious heart condition). About 60 adults will receive either a sirolimus-coated or paclitaxel-coated balloon. The main goal is to see which balloon leads to better artery healing and less inflammation 3 months after the procedure.
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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 to 80 years
- 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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects must meet all of the following criteria to be enrolled: 1. Age between 18 and 80 years old, both genders eligible; 2. Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator; 3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm; 4. Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%); 5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: 1. Total occlusion (TIMI 0 flow) lesion; 2. In-stent restenosis lesion; 3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting; 4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire; 5. Coronary artery bypass graft stenosis; 6. Confirmed ST-elevation myocardial infarction; 7. Cardiogenic shock or requiring mechanical respiratory and circulatory support; 8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia; 9. Severe renal insufficiency or undergoing hemodialysis; 10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues; 11. Systemic lupus erythematosus or other systemic autoimmune diseases; 12. History of stroke within 6 months prior to enrollment; 13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications; 14. Currently participating in other drug or interventional medical device clinical studies; 15. Other conditions deemed unsuitable for enrollment by the investigator.
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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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Fuwai hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- The heart rhythm threat hiding in heart attack wards
- Magnetic heart signals could help ER doctors spot hidden heart risk
- Heart arteries without metal: CT scans track Drug-Coated balloon results
- Can a Drug-Coated balloon beat a stent for tough heart attacks?
- Can a Triple-Drug cholesterol blitz make heart plaques safer?
- A 15-Minute audio break: could guided imagery soothe heart patients?