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临床试验/NCT02486315
NCT02486315已完成不适用

Treatment of Coronary ARtery bIfurcation Narrowing by AXxess Stent Implantation

Clinica Mediterranea0 个研究点目标入组 326 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
326
主要终点
device success

研究概览

简要总结

The Axxess™ Biolimus A9™ Eluting Coronary Bifurcation Stent System (AXXESS System; Biosensors, International, Morges, Switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. Although deemed ideal for lesions involving only the proximal MV (1,0,0 according to Medina classification ref), this device may be used also in more complex bifurcation lesions when additional DES are required in the distal MV and/or in the SB. In the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting AxxessTM stent for the treatment of bifurcation lesions in a real-world population.

详细描述

Despite a comprehensive understanding of the physiological and technical issues regarding the coronary bifurcations lesions, percutaneous coronary intervention (PCI) in this setting remains challenging. When compared with non-bifurcation lesions, treatment of bifurcation lesions is associated with increased adverse clinical events and inferior angiographic outcomes including procedural complications. This is due to several technical challenges, including both anatomical (proximal-to-distal vessel mismatch [tapering], angulation and calcification) and procedural (plaque shift, and side-branch [SB] closure) features. Current balloon-expandable drug-eluting stent (DES) have not been designed to treat the bifurcation lesions; in particular, the inability of DES to adequately scaffold and preserve the ostium of SB represents a the major reason of failure, because this is the most common site for restenosis. Recently a large variety of dedicated bifurcation stents have been developed in order to 1) provide an easier access to the SB and to scaffold more effectively its ostium, and 2) adapt to main vassel (MV) tapering, and to the bifurcation anatomy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • significant (≥70% diameter stenosis) bifurcation lesion;
  • MV reference diameter between 2.75 and 4.75 mm by visually estimated
  • SB reference diameter ≥2.25 mm by visual estimate;
  • bifurcation angle (between the distal MV and the SB) <70° by visual estimate

排除标准

  • patients with contraindications to prolonged dual-antiplatelet therapy,
  • known sensitivity to "limus" compounds, stainless steel, titanium, or nickel;
  • inclusion in others studies on bifurcation lesions; and
  • all bifurcation lesions not satisfying the angiographic inclusion criteria reported above

结局指标

主要结局

device success

时间窗: intraprocedural

successful deployment of the AxxessTM stent into the target lesion, without system failure or device-related complication.

次要结局

未报告次要终点

研究者

发起方
Clinica Mediterranea
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Briguori

MD, PhD

Clinica Mediterranea

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