Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Drug-coating balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be age ≥18 years. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission. 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. Subject is willing to comply with all protocol-required follow-up evaluations. 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). Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation. Target lesion must have visually estimated stenosis ≥50%. Target lesion length of side branch must be <10 mm by visual estimation. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel. Exclusion Criteria: Patient with STEMI (within 1-week from the onset of chest pain to admission). Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications. Patient is intolerable to dual anti-platelet therapy. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months. Patient is pregnant or nursing. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation. Restenotic lesion. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized. Severe calcification needing rotational atherectomy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will undergo 1:1 randomization to either PS-DCB which will be the treatment group or PS-NCB which will be the control group based on an online Clinical Research Data Management Platform provided by King Yee, Beijing CN. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1, 6, and 12 months after the index procedure. Angiographic follow-up is scheduled at 13 months.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PS-DCB<br>For PS-DCB group NC balloon dilating ostial side branch (SB) (1:1 ratio). 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. Kissing inflation using 2 noncomplian balloons. 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. Final kissing inflation and proximal optimal technique (POT). | Device: Drug-coating balloon<br>* Provisional stenting technique with DCB<br>* Other names: DCB;|
| Active Comparator: PS-NCB<br>For PS-NCB group NC balloon dilating ostial SB (1:1 ratio). Kissing inflation using 2 NC balloons. 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. Final kissing inflation and proximal optimal technique (POT). | Device: Drug-coating balloon<br>* Provisional stenting technique with DCB<br>* Other names: DCB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse cardiac event | MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR. | 12 months after angioplasty | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months after angioplasty | 
| Rate of periprocedural MI, Spontaneous MI, or target vessel MI | According to the DCB-BIF trial definition. | 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). | 12 months after angioplasty | 
| Rate of thrombosis | The safety endpoint was stent thrombosis (ST), according to the definition by Academic Research Consortium. | 12 months after angioplasty |