Nanjing First Hospital, Nanjing Medical University
Phase
Not applicable
Started
2020-09-08
Last updated
2025-12-15
Condition(s) studied
Coronary Artery Disease
Investigational drug(s) / intervention(s)
Drug-coating balloon
Drug-coating balloon: Provisional stenting technique with DCB
Study summary
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Rate of major adverse cardiac event — 12 months after angioplasty MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.
Trial sites (1)
Facility
City
Region
Status
Nanjing First Hospital
Nanjing
Jiangsu
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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