Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy

Study Overview
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Brief Summary
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The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.

Official Title
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Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy in the Treatment of True Bifurcation Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: paclitaxel DCB
* Device: DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old; Evidence of myocardial ischemia and indications of PCI, stable or unstable angina pectoris, or old myocardial infarction; Primary and bifurcated coronary artery lesions (Medina classification 1,1,1 or 1,0,1 or 0,1,1); Visual angiography of the main branch reference vessel diameter ≥2.5mm, and ≤4.0mm;Branch reference vessel diameter ≥2.0mm; Diameter stenosis of main and branch lesions ≥ 70%, and diameter stenosis of branch lesions ≥ 50%; Visual examination of residual stenosis of main branch lesions after pre-dilation ≤ 30% without vascular dissection or dissection with NHLBI classification A, B, C type. If 2 bifurcation lesions meet the inclusion requirements, only 1 lesion can be included in the study, and the other lesion can be treated or not treated as a non-target lesion. Exclusion Criteria: Main branch or branching target lesions require treatment with more than one device (DES or DCB); There is more than 1 non-target lesion requiring intervention on the target blood vessel; The distance between non-target lesion and target lesion is less than 10 mm; Main and branch lesions > 26 mm or branch lesions length BBB> mm; Left main lesion and its bifurcation lesion; Intra-stent restenosis or severe calcification; ST-segment elevation or non-ST-segment elevation myocardial infarction 7 days before surgery; Severe heart failure (NYHA-IV or left ventricular ejection fraction <35%); Cardiogenic shock; known to have renal failure (EGFR <30ml/min/1.73m2); Pregnant or lactating women, or women of reproductive age who had family planning or were unable to take adequate contraceptive measures during the study period; Any known allergic reactions or contraindications to the drug and coating or scaffold metal required for DCB in the study; Other DES or DCB treatment contraindications; Failing to sign an informed consent or having an expected life of less than 12 months; Other researchers consider it inappropriate to participate in this study.

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB strategy<br> | Device: paclitaxel DCB<br>* Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.<br>|
| Active Comparator: DES strategy<br> | Device: DES<br>* Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Target lesion failure (TLF) | Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization. | 12 months | 
| Number of Participants with net adverse clinical cardiovascular events (NACCE) | Net adverse clinical cardiovascular events, defined as cardiac death, clinically driven target vessel myocardial infarction, target lesion revascularization and major bleeding (BARC type 2, 3, 5 bleeding) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate | According to CAG, the residual stenosis of the main branch is less than 30% and the residual stenosis of the side branch is less than 50%. The blood flow is of TIMI III as well | 1-2 days | 
| Number of Participants with Target lesion failure (TLF) | Target lesion failure, defined as cardiac death, clinically driven target vessel myocardial infarction and target lesion revascularization | 1/6/24/36 month | 
| Number of Participants with Target lesion revascularization (TLR) | Target lesion revascularization, defined as clinically indicated percutaneous or surgical revascularization of the index lesion during follow-up, like using stent, balloon, coronary atherectomy, or CABG | 1/6/12/24/36 month | 
| Number of Participants with Target vessel revascularization (TVR) | Target vessel revascularization, defined as clinically indicated percutaneous or surgical revascularization of the target vessel during follow-up, like using stent, balloon, coronary atherectomy, or CABG | 1/6/12/24/36 month | 
| Clinical procedure time | The used time in the clinical procedure | during the procedure | 
| DAPT using time | The using time of DAPT | 1/6/12/24/36 month | 
| Number of Participants with Bleeding events（BARC2, 3, and 5） | Definite, probable, or possible thrombus in the device defined by ARC: Acute thrombus, subacute thrombus, late thrombus, and very late thrombus | 1/6/12/24/36 month | 
| Number of Participants with ARC defines stent thrombosis | The identification and possibility of stent thrombosis were included in the time ranges of acute, subacute, late, and late | 1/6/12/24/36 month |