Des Re-Endothelization for In-StEnt ResTenosis. The DESERT Study
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
- 否
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
Andrea Picchi
Md. PhD
S.M. Misericordia Hospital
