Comparison of Noncompliant Balloon With Drug-coating Balloon Angioplasties for Side Branch After Provisional Stenting for Patients With True Coronary Bifurcation Lesions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 784
- 试验地点
- 1
- 主要终点
- Rate of major adverse cardiac event
研究概览
简要总结
This study is designed to investigate whether drug-coated balloon (DCB) compared to conventional balloon angioplasty for side branch after provisional stenting will lead to lower rates of the composite endpoint of major adverse cardiac event (MACE) at 12 months. The individual components of MACE include cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). True bifurcation lesions were defined according to Medina classification.
详细描述
This is a prospective, multi-center, randomized-controlled, single blind, superiority trial that will include 25 international sites. The investigators aim to enroll 784 subjects with true coronary bifurcation lesions in native coronary arterial segments.
All patients with true coronary bifurcation lesions suitable for angioplasty will undergo 1:1 randomization either to PS (provisional stenting)-DCB or PS-NCB (noncompliant balloon) group using a randomization schedule blocked by site.
All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo angiography after successful stenting of the main vessel with ostium side branch visually estimated stenosis ≥70%. Data and images will be collected during the index procedure, during re-intervention in the case of clinically driven revascularization, and at the predefined 12-month clinical follow-up visit. All subjects will also undergo angiographic follow-up at 13 months.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will remain blinded until the final study results are released.
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
- •Subject must be age ≥18 years.
- •Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
- •Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.
- •Subject is willing to comply with all protocol-required follow-up evaluations.
- •Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
- •Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
- •Target lesion must have visually estimated stenosis ≥50%.
- •Target lesion length of side branch must be <10 mm by visual estimation.
- •Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.
排除标准
- •Patient with STEMI (within 1-week from the onset of chest pain to admission).
- •Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
- •Patient is intolerable to dual anti-platelet therapy.
- •Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
- •Patient is pregnant or nursing.
- •Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
- •Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
- •Restenotic lesion.
- •Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
- •Severe calcification needing rotational atherectomy.
结局指标
主要结局
Rate of major adverse cardiac event
时间窗: 12 months after angioplasty
MACE defined as the composite of cardiac death, myocardial infarction (MI), and clinically driven TLR.
次要结局
- Rate of clinically-driven TLR or TVR(12 months after angioplasty)
- Rate of periprocedural MI, Spontaneous MI, or target vessel MI(12 months after angioplasty)
- Rate of thrombosis(12 months after angioplasty)
- Rate of all-cause death or cardiac death(12 months after angioplasty)
研究者
Shaoliang Chen, MD
Vice President
Nanjing First Hospital, Nanjing Medical University