An interventional study of Drug-coating balloon in Coronary Artery Disease, sponsored by Nanjing First Hospital, Nanjing Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Nanjing First Hospital, Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments.
All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 784 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For PS-DCB group 1. NC balloon dilating ostial side branch (SB) (1:1 ratio). 2. DCB dilating SB. Specifically, the DCB, which had to be 2-3 mm longer on each side than the predilatation balloon, was inflated at nominal pressure for 30\~ 60 s. The ratio of the DCB diameter to the nominal diameter of the SB was recommended to be between 0.8 and 1.0. DCB should be delivered to the lesion within 2 min after entering human body. 3. Kissing inflation using 2 noncomplian balloons. 4. Stenting side branch with T and protrusion (TAP) technique if any of the following issues was observed after kissing balloon inflation: \>type C dissection or thrombolysis in myocardial infarction (TIMI) flow \<3. 5. Final kissing inflation and proximal optimal technique (POT).
Device: Drug-coating balloon
For PS-NCB group 1. NC balloon dilating ostial SB (1:1 ratio). 2. Kissing inflation using 2 NC balloons. 3. Stenting side branch with TAP technique if any of the following issues was observed after kissing balloon inflation: \>type C dissection or thrombolysis in myocardial infarction (TIMI) flow \<3. 4. Final kissing inflation and proximal optimal technique (POT).
Device: Drug-coating balloon
Provisional stenting technique with DCB
Also known as: DCB
Rate of major adverse cardiac event
MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.
Time frame: 12 months after angioplasty
Rate of all-cause death or cardiac death
In general, all deaths are considered cardiac unless an alternate cause is unequivocally established, even among subjects with serious noncardiac comorbidities.
Time frame: 12 months after angioplasty
Rate of periprocedural MI, Spontaneous MI, or target vessel MI
According to the DCB-BIF trial definition.
Time frame: 12 months after angioplasty
Rate of clinically-driven TLR or TVR
Clinically driven revascularization includes repeat PCI or coronary artery bypass graft (CABG) for recurrent or persistent symptomatic ischemia and can be defined according to the relationship to the index PCI (target lesion).
Time frame: 12 months after angioplasty
Rate of thrombosis
The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium.
Time frame: 12 months after angioplasty
Rate of Angiographic success
PCI is considered successful for lesions treated with stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 10% and the final TIMI flow grade is 3. PCI is considered successful for lesions treated without stent implantation if the residual diameter stenosis based on visual estimation is less than or equal to 20% and the final TIMI flow grade is 3.
Time frame: 1 day
Rate of clinical procedural success
Successful PCI without MACE during hospital stay.
Time frame: 7 day
Crossover rate
From single stent technique to two-stent technique
Time frame: 1 day
Plan to share: No
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Nanjing First Hospital, Nanjing Medical University