A prospective post marketing clinical follow up study to evaluate the safety and performance of SAVIOUR-DES System in Real World Indian population
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Device Oriented Composite endpoints at 1 year post index procedure
研究概览
简要总结
Drug-eluting stents (DES) are a significant advancement in percutaneous coronary interventions (PCI), reducing the need for repeat revascularization compared to bare metal stents. However, the potential for re-narrowing of the vessel and complications from permanent polymers in earlier DES models have limited their long-term success. Permanent polymers, while effective in prolonging drug release, have been associated with chronic inflammation and adverse clinical events. Biodegradable polymers offer a promising alternative, as they degrade into inert products after serving their function, potentially avoiding these issues. DES are made from cobalt chromium alloy, coated with a drug-polymer matrix, and delivered via a balloon catheter. The stents are available in various sizes and, once implanted, promote vessel healing through neointimal growth and reendothelialization.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient who can provide informed consent form in writing to provide date for the study.
- •Patient that need a treatment with drug eluting stent.
排除标准
- •Prior stenting in target or non target vessel within 90 days before index procedure patient participating in other study.
结局指标
主要结局
Device Oriented Composite endpoints at 1 year post index procedure
时间窗: Clinical endpoints measured at 1 month 6 months and 1 year post index procedure | 1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization.
1 Cardiac Death
时间窗: Clinical endpoints measured at 1 month 6 months and 1 year post index procedure | 1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization.
2 Target Vessel related Myocardial Infarction (TV-MI) and
时间窗: Clinical endpoints measured at 1 month 6 months and 1 year post index procedure | 1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization.
3 Clinically driven Target Lesion Revascularization (TLR)
时间窗: Clinical endpoints measured at 1 month 6 months and 1 year post index procedure | 1 Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, any stroke and any revascularization.
次要结局
- To determine any undesirable side effects under normal conditions of use and assess whether the risks constitute weighed against the intended performance of the Drug Eluting coronary Stent System.
研究者
Dr Yash Paul Sharma
Postgraduate Institute Medical Education & Research