The European Bifurcation Club Randomized Trial of Stepwise Provisional Stenting Versus Drug Coated Balloon Therapy for Non-left Main True Coronary Bifurcations - EBC DCB Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Ceric Sàrl
- 入组人数
- 750
- 主要终点
- Bifurcation Orientated Composite Endpoint (BOCE)
研究概览
简要总结
Clinical outcomes are worse in patients with coronary artery bifurcation lesions, even if commonly encountered in clinical practice. The use of drug coated balloons within bifurcation lesions offers the acute advantage of a more straightforward procedure, without recrossing and deformation of a stent. Thus, the primary objective of this study is to determine if Drug Coated Balloon treatment of non-left main true coronary artery bifurcation lesions is non-inferior (similar) to a provisional strategy with Drug Eluted Stent deployment.
详细描述
The EBC DCB study is an investigator-initiated, prospective, multi-centre, open-label, randomized (1:1) non-inferiority trial.
Patients with non-left main bifurcations requiring revascularisation and both the main vessel and side branch significantly diseased ( ≥2.5mm and Medina 1/1/1, 1/0/1 or 0/1/1), constitute the source population. Patients with no more than two additional coronary disease may be considered for the study, with only one bifurcation lesion included.
Patients, pre-selected by their referring physicians, will be screened for eligibility by the study team. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. 20 sites will be involved, in 7 European countries and South Korea, for a total of 750 patients. After a 2-years recruitment period, the trial will include a Follow-Up period at 6-months, 1-year, 3-years, 5-years and 8-years. The 1-year check point will constitute the primary endpoint where the Bifurcation Orientated Composite Endpoint (BOCE) will be analyzed for non-inferiority (further analysis for superiority, if non-inferiority met).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •True non-left main bifurcation disease with both MV and SB involvement (i.e Medina 1/1/1, 1/0/1, 0/1/1)
- •Bifurcation lesion responsible for an acute or chronic coronary syndrome with at least one of the following:
- •≥70% angiographic MV and SB diameter stenosis
- •Positive non-invasive testing for ischaemia
- •Positive coronary physiology for ischaemia
- •Significant SB as described by diameter stenosis ≥50% and all of the following:
- •SB length ≥73mm
- •SB diameter ≥2.5mm
- •Absence of another SB emerging distally from the MV
- •Non-dominant circumflex artery, if SB is a diagonal branch.
排除标准
- •Patients <18 years old
- •STEMI <48 hours
- •Cardiogenic shock
- •Chronic total occlusion involving target bifurcation vessels
- •In-stent restenosis
- •Patient life expectancy <12 months
- •>2 other coronary lesions (target or non-target) planned for treatment
- •SYNTAX score >32
- •Platelet count ≤50x109/mm3
- •Left ventricular ejection fraction ≤20%
- •Participation in another investigational drug or device study
- •Patient unable to give informed consent
研究组 & 干预措施
Stepwise Provisional Stent Strategy
Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition.
Finally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure.
Further SB treatment is required only if <TIMI 3 flow, significant stenosis >70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory.
干预措施: Percutaneous Coronary Angioplasty (Procedure)
Stepwise Provisional Stent Strategy
Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). Stenting of the MV is undertaken with a wire jailed in the SB to preserve SB flow and access. Stent diameter is chosen according to the diameter of the distal MV. Following stent deployment, the stent portion in the proximal MV is dilated with a short non-compliant balloon (POT technique) to achieve full expansion and apposition.
Finally, after POT technique, SB is rewired and a kissing balloon inflation (KBI) is undertaken to address any plaque or carina shift and to open stent struts. Thus, non-compliant balloons sized to the diameter of the distal MV and SB are sequentially inflated at high pressure, and then simultaneously at low pressure.
Further SB treatment is required only if <TIMI 3 flow, significant stenosis >70% or significant dissection. Thus, a side vessel stent implantation followed with KBI are mandatory.
干预措施: Stepwise Provisional Stent Strategy (Device)
Drug Coated Balloon Strategy
Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory.
Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure.
If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB.
After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory.
The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation.
干预措施: Percutaneous Coronary Angioplasty (Procedure)
Drug Coated Balloon Strategy
Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory.
Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure.
If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB.
After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory.
The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation.
干预措施: Drug Coated Balloon Strategy (Device)
Drug Coated Balloon Strategy
Coronary guide wires are passed into both the main vessel (MV) and side branch (SB). If residual stenosis remains >30%, or TIMI flow<3, or dissection propagation, the stenting of the MV is mandatory.
Otherwise, a paclitaxel-drug coated balloon (DCB) is inflated in the prepared SB for 60 seconds at nominal pressure.
If residual stenosis remains >50%, or TIMI flow<3, or dissection propagation, the operator will decide between prolonged balloon dilatation (1-2 minutes) or stent implantation, in the SB.
After SB treatment, MV is treated with a DCB at nominal pressure only, sized 1:1 with the proximal MV, for 60 seconds. If result is unacceptable, MV stenting followed with kissing balloon inflation and DCB or stent implantation into SB, are mandatory.
The procedure is complete when the MV has residual stenosis <30%, has TIMI 3 flow and has no dissection propagation ; when the SB has residual stenosis <50%, has TIMI 3 flow and has no dissection propagation.
干预措施: Cross-Over Stepwise Provisional Stent Strategy (Device)
结局指标
主要结局
Bifurcation Orientated Composite Endpoint (BOCE)
时间窗: At 1-year, after the day of enrollment
The BOCE is defined by: * cardiovascular death, * target bifurcation-related myocardial infarction or * target bifurcation revascularisation
次要结局
- Angina index(At 1, 3, 5 and 8-years)
- Bifurcation Orientated Composite Endpoint (BOCE)(At 3, 5 and 8-years)
- Individual components of the Primary Endpoint(At 1, 3, 5 and 8-years)
- Individual components of the Safety Composite Endpoint(At 1, 3, 5 and 8-years)
- BARC 3 or 5 bleeding rate(At 1, 3, 5 and 8-years)
- Safety Composite Endpoint(At 1, 3, 5 and 8-years)
- Angina status(At 1, 3, 5 and 8-years)