A Prospective Multicenter Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Rate of target lesion revascularization (TLR) at 12-month.
研究概览
简要总结
A Prospective Multi-center Randomized Trial Assessing the Efficacy and Safety of Active Transfer of Plaque vs. Provisional T Stenting for the Treatment of Unprotected Distal Left Main Bifurcation Lesions
详细描述
It is a prospective, multi-center, randomized, open-label, non-inferiority trial. A total of 316 subjects from around 20 selected hospitals will be randomized on a 1:1 basis to either Active transfer of Plaque (ATP) stenting technique or Provisional T stenting technique.
In the ATP treatment of bifurcation lesions, by the balloon pre-dilation in the target side branch, the plaque will be actively transferred from side branch to main vessel. Subsequently, the plaque will be fixed by the expansive stent in main vessel.As to the provisional T treatment, provisional T stenting is the typic step-T stenting. In brief, two wires are advanced to distal MV and SB. Pre dilation is left at operator's discretion, however, pre dilating SB is not encouraged. Kissing balloon inflation before stenting MV is left at operator's discretion. A stent with stent/artery ratio of 1.1:1 is inflated in MV. Rewire to SB is also left at operator's discretion. FKBI is recommended if there is at least one of following: residual stenosis>70%, >type B dissection and TIMI flow<3.
All patients will be followed clinically at 1-, 6- 12- and 24-month after stent implantation. Repeat angiography will be performed in all patients at 13 months after the index procedure.
The primary endpoint of the trial is the rate of TLR at 12-month follow-up.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be at least ≥18, ≤80 years of age.
- •Patient has Stable/unstable angina or NSTEMI
- •Patient has STEMI>24-hour from the onset of chest pain to admission.
- •LMb (Medina 0,1,1；1,1,1；0,1,0 ；1,1,0).
- •Patient is eligible for elective percutaneous coronary intervention (PCI) .
- •Patient is an acceptable candidate for coronary artery bypass grafting (CABG).
- •Patient (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed; patient is willing to comply with all protocol-required follow-up evaluations
排除标准
- •Patient with STEMI (within 24-hour from the onset of chest pain to admission).
- •Patient has known allergy to the study stent system or protocol-required concomitant medications that cannot be adequately pre-medicated (everolimus, aspirin, contrast media, acrylic acid, Stainless steel).
- •Patient has 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 12 months after the index procedure.
- •Patient with severe calcified lesions needing rotational atherectomy.
- •Left main In Stent Restenosis.
- •Investigator consider that patients don't fit to participate in the study.
结局指标
主要结局
Rate of target lesion revascularization (TLR) at 12-month.
时间窗: 12 months
次要结局
- Classification score of Canadian Cardiovascular Society (CCS) angina or Braunwald class.(Up to 2 years)
- Clinically cardiovascular endpoints at 1-, 6- , 12- and 24-month, including all-cause death, MI and any revascularization.(Up to 2 years)
- Stent thrombosis which is defined according to Academic Research Consortium (ARC) definition, including definite, probable and possible stent thrombosis.(Up to 2 years)
- Rate of target lesion failure(TLF) at 1-, 6-,12- and 24-month after procedure(Up to 2years)
- The net gain of lumen diameter; in-segment late loss (LL) and ISR of main vessel and side branch at 13-month.(13 months)
研究者
Yang Qing
MD
Beijing Anzhen Hospital