ACOART SCB BIF: Treatment of Coronary Bifurcation Lesion by Sirolimus Coated Balloon vs Paclitaxel Coated Balloon

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to examine the treatment of coronary bifurcation lesion with a sirolimus coated balloon versus a paclitaxel coated balloon. This trial is designed as prospective, multicenter, randomized and open-label.

Official Title
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A Prospective, Multicenter, Random Controlled Clinical Trail to Evaluate the Effectiveness and Safety of Sirolimus Coated Balloon Versus a Paclitaxel Coated Balloon in the Treatment of Coronary Bifurcation Lesion

Conditions
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Coronary Bifurcation Lesions

Intervention / Treatment
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* Device: Sirolimus Coated Balloon Catheter
* Device: a Paclitaxel Coated Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years old and ≤75 years old Diagnosed as stable or unstable angina pectoris, asymptomatic myocardial ischemia or old myocardial infarction, or recent myocardial infarction in stable stage. Eligible for balloon dilatation or stent implantation. Subject (or legal guardian) understands the study requirements and procedures and provides written Informed Consent before any study tests or procedures are performed Exclusion Criteria: AMI occurred within 7 days before operation The subjects had congestive heart failure or the heart function was classified as NYHA/KillipIV. Left ventricular ejection fraction (LVEF) < 35% History of heart transplantation The subjects had severe arrhythmias, such as high-risk ventricular extrasystole and / or ventricular tachycardia. The subjects had stroke, gastrointestinal bleeding or active ulcers, or had a high risk of bleeding in the past 6 months. Active bleeding physique or blood coagulation disorder Known renal insufficiency（eGFR<30ml/min） Contraindicated to anticoagulants or antiplatelet agents Has a history of percutaneous coronary intervention (PCI) within 6 months before enrollment. Has contraindications for coronary artery bypass grafting known to be allergic to aspirin, heparin, contrast agents, paclitaxel and sirolimus Life expectancy less than 12 months, or unable to complete a 12-month follow-up Pregnant or lactating females, or who plan to become pregnant during a follow-up period of 1 year after operation The subjects have participated in other drug property studies or device studies that have not yet completed the main end point. Angiographic Inclusion Criteria: One target lesion (bifurcation lesion) in the coronary artery is allowed, and if there are coexistent non-bifurcated lesions requiring PCI intervention, only one lesion was accepted at most, and the target lesion should be treated after successful PCI treatment of non-target lesion. Target Lesion located in native coronary artery must be de novo Medina classification should be (1.1.1, 1.0.1, 0.1.1) Main branch of target lesion (%DS is ≥70% or ≥50% with clinical symptoms ) is suitable for stent implantation Target Lesion located in main branch should be covered by DES. Moreover, the residual stenosis ≤ 30%, TIMI flow is 3, no complications and branch vessel opening stenosis ≥ 70%. Reference vessel diameter of the branch is 2.0-4.0mm (by visual) Target lesion length ≤ 36mm (by visual) Angiographic Exclusion Criteria: Target or non-target lesion located in left main Subjects who have non-target lesions of bifurcation The target lesion is trifurcation or multifurcation lesion. Main branch of target lesion located within 3 mm from the ostium of LAD or LCx or RCA The branch lesion is a diffuse long lesion, which could't covered by one DCB. Main or side branch is occlusive lesion, which TIMI flow is 0. Aneurysm existed in the blood vessel at the target lesion Side branch severely calcified or tortuous The blood pressure was too low to tolerate intracoronary injection of ≥ 100ug nitroglycerin Failure pre-dilatation of the side branch ostium (residual stenosis > 30% ,the blood flow in TIMI is not up to grade 3, or has dissection of type C or above according to NHLBI grade)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>a Sirolimus Coated Balloon | Device: Sirolimus Coated Balloon Catheter<br>* a Sirolimus Coated Balloon Catheter designed and produced by Acotec<br>|
| Active Comparator: Control Group<br>a Paclitaxel Coated Balloon Catheter | Device: a Paclitaxel Coated Balloon Catheter<br>* a Paclitaxel Coated Balloon Catheter(trade name:Bingo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure. | Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)*100% at 9 months post procedure. | 9 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device success | Defined as the rate of successful delivery and withdrawal of the delivery catheter, and achieving a final in-lesion residual stenosis less than 30% and TIMI flow grade 3 by using the assigned device only. | Immediately after procedure | 
| Rate of lesion success | Defined as the rate of achieving a final in-lesion residual stenosis < 30% by visual estimate and TIMI flow grade 3 by using any percutaneous method. | Immediately after procedure | 
| Rate of procedure success | Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) . | Immediately after procedure | 
| Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE） | Defined as a composite rate of cardiac death, target vessel-related MI, or ischemia-driven TLR events at 30 days, 6 months, 9 months and 12 months post procedure. | 30 days, 6 months, 9 months, 12 months post procedure | 
| Rate of patient-related composite endpoints (PoCE） | Defined as a composite rate of all cause death, all cause-related MI or TLR events at 30 days, 6 months, 9 months and 12 months post procedure. | 30 days, 6 months, 9 months, 12 months post procedure | 
| Diameter stenosis rate | Defined as the rate of restenosis (>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure. | 9 months post procedure | 
| Late lumen loss (LLL) | Defined as the difference of minimum lumen diameter (MLD) from post procedure to 9 months follow-up, including late lumen loss of main vessel and side branch. | 9 months post procedure | 
| Angiographic binary restenosis (ABR) rate | Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure. | 9 months post procedure | 
| Rate of composite safety endpoint | Defined as a composite rate of all-cause death, cardiogenic death, myocardial infarction, target vessel-related myocardial infarction, incidence of thrombotic events (acute, subacute, late) defined by ARC at 12 months post procedure. | 12 months post procedure |