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临床试验/NCT01243099
NCT01243099已完成不适用

Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study

S.M. Misericordia Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2010年11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
31
试验地点
1
主要终点
Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.

研究概览

简要总结

The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is supported by two different observations: first, when a DES is implanted to treat a BMS restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly characterized by extracellular matrix with a regular surface. In this case stent malposition is less likely to occur compared to atherosclerotic lesion whose surface is often more irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is implanted to treat restenosis, reendothelialization is likely to occur earlier. If this hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES implantation on BMS restenosis with a clinical advantage in terms of bleeding risk. Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES; thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and to benefit from a shorter period of dual antiplatelet therapy.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suitable for implantation of everolimus-eluting stents (Xcience V, Xience Prime) because of stable/unstable angina or silent myocardial ischemia due to:
  • Group A: single BMS restenosis (> 50% of luminal diameter)
  • Group B: single de-novo lesion (> 50% of luminal diameter)

排除标准

  • contraindications to dual antiplatelet therapy
  • acute myocardial infarction within the previous 48 hours
  • significant left main coronary artery disease
  • reference vessel diameter < 2.5 mm,
  • hemodynamic instability
  • chronic kidney disease with serum creatinine > 2 mg/dl
  • pregnancy
  • allergy to contrast agent, everolimus, aspirin, clopidogrel
  • life expectancy < 24 months
  • patients with possible low adherence to medical therapy

结局指标

主要结局

Prevalence of uncovered struts evaluated by OCT analysis at six-month follow-up.

时间窗: Measured will be assessed six-month after coronary angioplasty

次要结局

未报告次要终点

研究者

发起方
S.M. Misericordia Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andrea Picchi

Md. PhD

S.M. Misericordia Hospital

研究点 (1)

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