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临床试验/CTRI/2021/09/036701
CTRI/2021/09/036701已完成不适用

Immediate procedural safety and long-term efficacy of Ultra-long 48 mm Xience-Xpedition stents: A real world experience from India

Department of Cardiology1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Major adverse cardiac events (MACE) – Death /MI/ reintervention

研究概览

简要总结

Cardiovascular disease (CVD) is the leading cause of mortality in India. Percutaneous coronary intervention (PCI) is a commonly used treatment modality for patients with coronary artery disease. Drug eluting stents (DES) are more efficient than the bare metal stents. Long lesions require treatment with longer balloons and stents, leading to greater arterial injury, which might result in exaggerated neointimal hyperplasia. Long DES is also an independent risk factor for subsequent myocardial infarction, which maybe associated with increased mortality. longer lesions can be treated either overlapping of two shorter stents or placement of a single long stent. Current data indicate that both stent length and stent overlap are associated with major adverse cardiac events. Stent overlap has been associated with increased neointimal proliferation and lumen loss due to delayed healing and increased inflammation. New stent designs with increase length are emerging as an increasingly utilized tool in PCI. The longest stent, called ultra long stent, approved by the USFDA is 38mm. In India, 48mm Xience Xpedition (Abbott Vascular, Santa Clara, Calif) is DGCI approved. The Xience Xpedition 48 mm EES is a proprietary L-605 cobalt-chromium alloy stent pre-mounted on a rapid exchange delivery system. The abluminal surface of the device is coated in a thin layer of durable fluoropolymer, which is used as a carrier for Everolimus. There is no large data available studying the efficacy of stents greater than 38mm. We thereby sought to assess the immediate procedural success and long term efficacy and safety ultra long 48mm Xience xpedition stents in our study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All patients who underwent percutaneous coronary intervention using Xience Xpedition 48 mm long stent (Abbott vascular Santa Clara, CA ) who will be willing to give informed consent.

排除标准

  • Patients who will not give consent Patients who could not be contacted.

结局指标

主要结局

Major adverse cardiac events (MACE) – Death /MI/ reintervention

时间窗: follow up at least 1 year

次要结局

  • Death, MI, repeat revascularization, procedural success, clinical restenosis which is defined as target lesion revascularization or positive stress test in the intervened vessel or more than 50% in stent stenosis in the angiogram(Follow up of at least 1 year)

研究者

发起方
Department of Cardiology
申办方类型
Research institution and hospital

研究点 (1)

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