Coronary Bifurcation Lesions
Conditions
Brief summary
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.
Interventions
DEVICESirolimus Coated Balloon Catheter
a Sirolimus Coated Balloon Catheter designed and produced by Acotec
DEVICEa Paclitaxel Coated Balloon Catheter
a Paclitaxel Coated Balloon Catheter(trade name:Bingo)
Sponsors
Shanghai Zhongshan Hospital
Acotec Scientific Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter stenosis rate of bifurcation lesion determinated by Digital Substraction Angiography (DSA) at 9 months post procedure. | 9 months post procedure | Defined as (1-minimum lumen diameter of target lesion/reference vessel diameter)\*100% at 9 months post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of lesion success | Immediately after procedure | 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. |
| Rate of procedure success | Immediately after procedure | Defined as the rate of achieving lesion success without MACE (composite of cardiac death, MI and TLR events) . |
| Rate of target lesion failure (TLF) or device-related composite endpoints (DoCE） | 30 days, 6 months, 9 months, 12 months post procedure | 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. |
| Rate of patient-related composite endpoints (PoCE） | 30 days, 6 months, 9 months, 12 months post procedure | 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. |
| Rate of device success | Immediately after procedure | 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. |
| Late lumen loss (LLL) | 9 months post procedure | 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. |
| Angiographic binary restenosis (ABR) rate | 9 months post procedure | Defined as the percentage rate of binary restenosis determined by angiographic at 9 months post procedure. |
| Rate of composite safety endpoint | 12 months post procedure | 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. |
| Diameter stenosis rate | 9 months post procedure | Defined as the rate of restenosis (\>50% diameter stenosis) of main vessel after 9 months at 9 months post procedure. |
Countries
China
Contacts
Primary ContactLu Hao
Outcome results
None listed