New balloon technique may lower heart risks after stenting
NCT ID NCT04242134
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether using a drug-coated balloon (DCB) instead of a standard balloon for the side branch of a heart artery after stenting can reduce the chance of major heart problems like heart attack or death within one year. About 784 adults with coronary artery disease and true bifurcation lesions (where the main artery splits) are taking part. The goal is to see if the DCB approach leads to fewer heart-related events.
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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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784 people
The number who actually took part.
- Started
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Sep 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
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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: 1. Subject must be age ≥18 years. 2. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. 3. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed. 4. Subject is willing to comply with all protocol-required follow-up evaluations. 5. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI). 6. Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation. 7. Target lesion must have visually estimated stenosis ≥50%. 8. Target lesion length of side branch must be \<10 mm by visual estimation. 9. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel. Exclusion Criteria: 1. Patient with STEMI (within 1-week from the onset of chest pain to admission). 2. Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications. 3. Patient is intolerable to dual anti-platelet therapy. 4. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. 5. Patient is pregnant or nursing. 6. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. 7. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. 8. Restenotic lesion. 9. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized. 10. Severe calcification needing rotational atherectomy.
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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
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Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
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