Randomized Controlled Trial of Simple CROSSsover Versus Side Branch Opening on Clinical Outcomes in Patients With Non-Left Main BIfurcation LeSion (CROSS-COBIS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Target-lesion failure
研究概览
简要总结
Hypothesis:
Simple crossover strategy would be non-inferior to SB opening strategy in the risk of target lesion failure (TLF) in patients with angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.
A total of 1000 patients (500 per each group) with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion will be enrolled. Patients will be randomized to either the simple crossover strategy group or SB opening strategy group at the time of enrollment with 1:1 ratio. Stratified randomization according to participating center, clinical presentation (acute coronary syndrome or stable ischemic heart disease), and type of bifurcation lesions (true or non-true) will be performed.
详细描述
Despite advances in stenting techniques and devices, percutaneous coronary intervention (PCI) for bifurcation lesions remains one of the most challenging and complex procedures. Current guidelines recommend 1-stenting with provisional side branch (SB) approach should be an initial treatment strategy for the bifurcation lesions, based on the previous results of several randomized trials. However, the standardization of the provisional strategy is limited. In particular, there is a recommendation on the treatment technique for SB when SB intervention is required, but It has not been decided in which cases SB treatment is necessary, in the latest European Bifurcation Club (EBC) consensus document.16 In previous studies, the criteria for performing SB opening after MV stent intervention in the 1-stenting with provisional SB approach were varied. In the DK-CUSH II (Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) or CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) trials, SB intervention was performed when the SB diameter stenosis more than 50%, grade B or higher dissection, or blood flow disturbance (TIMI flow 2 or less) after MV stent insertion. On the other hand, in the Nordic trial, the authors applied strict criteria for SB intervention after MV stent insertion (TIMI flow 2 or less only). Furthermore, there have been conflicting results regarding the clinical and angiographic outcomes of the jailed SB opening strategy after the main vessel (MV) stenting, compared with the simple crossover strategy for non-left main bifurcation lesion.
On this background, this trial aims to compare the clinical outcomes between simple crossover and side branch opening strategies in patients with the angiographically compromised SB (visually SB stenosis ≥50%) after provisional MV stenting for non-left main bifurcation lesion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Subject must be at least 19 years of age
- •(2) Patients with non-left main bifurcation lesion (SB diameter ≥2.3 mm)
- •(3) Target lesions amenable for 1-stenting with provisional SB approach by operators' decision
- •(4) Angiographically compromised SB (visual SB stenosis ≥50%) after provisional MV stenting
排除标准
- •(1) Target lesions requiring elective 2-stenting technique by operators' decision (Observation Group 1)*
- •(2) Patients who inevitably require SB intervention after MV stenting, as follows. (Observation Group 2)*
- •Reduced SB TIMI flow (≤2) after MV stenting
- •SB dissection after MV stenting (≥ Type C)
- •(3) Patients without SB compromise after MV stenting (visually SB stenosis <50%) (Observation Group 3)*
- •(4) Cardiogenic shock (Killip class IV) at presentation
- •(5) Patients with significant valvular heart disease or severe left ventricular systolic dysfunction (ejection fraction <35%)
- •(6) Pregnancy or breast feeding
- •(7) Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •(8) Unwillingness or inability to comply with the procedures described in this protocol
研究组 & 干预措施
Simple crossover arm
This arm will receive the main vessel stenting only (with proximal optimization technique).
干预措施: Simple Crossover (Procedure)
Side branch opening arm
This arm will receive a side branch opening procedure after the main vessel stenting.
干预措施: Side branch opening (Procedure)
结局指标
主要结局
Target-lesion failure
时间窗: up to 2 years of median follow-up (till 1 year after the last patient enrollment)
a composite of cardiac death, myocardial infarction, and target-lesion revascularization
次要结局
- Total amount of contrast use(at 1 day)
- Cardiac death(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Any revascularization(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- All-cause death(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Target-vessel myocardial infarction(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Target-lesion revascularization(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Stent thrombosis(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Bleeding(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Incidence of contrast induced nephropathy(72 hours after the index procedure)
- Myocardial infarction(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Target-vessel revascularization(up to 2 years of median follow-up (till 1 year after the last patient enrollment))
- Total procedure time(at 1 day)
研究者
NAM, Chang-Wook
Professor
Keimyung University Dongsan Medical Center