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临床试验/NCT03769038
NCT03769038已完成不适用

Long-term Outcomes of Successful Chronic Total Occlusion Percutaneous Coronary Interventions Using the Antegrade and Retrograde Dissection and Re-entry Approach

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
the bionary in-stent restenosis of CTO vessels at the scheduled angiographic follow-up at 13 months.

研究概览

简要总结

BACKGROUND:Chronic total occlusion (CTO) angioplasty is one of the most challenging procedures remaining for the interventional operator. Today, with contemporary CTO negotiation available strategies and significant operator expertise, the literature reports a 50%-95% success rate for recanalizing CTOs. But PCIs of CTO lesions still carry a high rate of in-stent restenosis (ISR). Because previous reports have not specifically compare contemporary antegrade and retrograde dissection and re-entry dissection (ADR/RDR) technique on the long-term impact of ISR, so the investigators focused on the objective.

OBJECTIVES: This study hope to evaluate the frequency of angiographic ISR and further elucidate some ISR related higher risk factors among CTO PCI patients in intimal stent group using antegrade or retrograde wire escalation (AWE/RWE) techniques and sub-intimal stent group using contemporary antegrade or retrograde dissection and re-entry (ADR and/or RDR).

METHODS: A total of 300 consecutive selected patients with CTO lesion who will undergo successful revascularization by AWE/RWE and ADR/RDR techniques treatment will be enrolled in this prospective multicenter registry from December 1 2018 to December 31 2019. The primary study endpoint of the protocol is the bionary in-stent restenosis of CTO vessels at angiographic follow-up about 13 months. The secondary endpoints are: 1) CTO technique and procedure success rate; and 2) in-hospital and 30 days MACE (Cardiac death, acute myocardial infarction, urgent repeat tratget vessel revascularization with either pericardiocentssis or surgery and stroke and stent thrombosis and stroke); 6months and 1-year and 2-year MACE including death, MI, and target CTO vessel revascularization and stroke ; and 3) Restenosis scores (R-scores) of related risk factors.

详细描述

METHODS

  1. Trial overview and study population.

① This clinical trial is a prospective, exploratory, nonrandomized, multicenter trial evaluating the frequency of angiographic restenosis and clinical outcomes among patients undergoing CTO PCI in intimal stent group using antegrade or retrograde wire escalation (AWE/RWE) techniques and sub-intimal stent group using contemporary antegrade or retrograde dissection and re-entry (ADR or RDR) with everolimus-eluting stents (XIENCE Coronary Stent).

②According to high patient's volume registry studies in CTO lesions, the patients percentage of ADR or RDR strategy application was just only 20-25%36-37. If to get 60 patients for ADR or RDR strategies, the minimum CTO number are 300 patients. So in this registry study, 300 CTO cases, to which PCI will be attempted, are prospectively enrolled from Dec 1st 2018 to Dec 31st 2019 in the CTO registries of ten centers. The study was approved by the institutional review board at each site. For patients with multiple treated CTO, only the first CTO attempted was considered for the analysis.

③ Exclusions included age <18-years-old or >85-years-old, left ventricular ejection fraction ≦30%, allergy to medications (antiplatelet drugs, heparin, metal alloys, or contrast agents), a planned surgery within 6 months of PCI or planned thrombolysis, pregnant, a life expectancy of <6 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • CTO time >3months and CTO length >20mm

排除标准

  • age <18-years-old or >85-years-old,
  • left ventricular ejection fraction ≦30%,
  • allergy to medications (antiplatelet drugs, heparin, metal alloys, or contrast agents),
  • a planned surgery within 6 months of PCI or planned thrombolysis,
  • pregnant,
  • a life expectancy of <6 months.

结局指标

主要结局

the bionary in-stent restenosis of CTO vessels at the scheduled angiographic follow-up at 13 months.

时间窗: 13months after PCI

the diamater of stents less than 50%

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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