Post Market clinical Follow up to evaluate clinical outcome after Implantation of Biodegradable Polymer based Sirolimus Eluting Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Incidence of Major Adverse
研究概览
简要总结
This PMCF plan is developed to conduct a prospective multicentre registry study to evaluate the long-term safety of the Biodegradable Polymer based Sirolimus Eluting Coronary Stent System Post Marketing Surveillance (PMS) for Long Term Follow-up (5 Years), in patients of coronary artery disease (CAD) that qualify for percutaneous coronary intervention with Sirolimus drug eluting coronary stent (DES). The most known and the most frequent heart diseases are caused by atherosclerosis, a process of vessel wall degradation and calcification, leading to narrowing and/or occlusion of the blood vessels. This is one of the major causes of deaths in countries of developed world. Lifestyle modifications of healthy eating and healthy habits (quit smoking, regular exercise) are largely advised at the onset of atherosclerosis. However, in severe conditions it is imperative to perform Percutaneous Coronary Intervention.
This study seeks to evaluate the clinical outcomes of BPSS for Long Term PostMarket Clinical Follow-up for Long Term Follow-up (5 Years), in various clinical sites/hospitals of India. Based on the review of clinical studies published between 2001 to 2018, it is assumed that as the outcome of this Post-Market Clinical Follow-up (PMCF) study of Biodegradable Polymer based Sirolimus Eluting Coronary Stent Systems in patients of CAD amenable to percutaneous coronary intervention (PCI) should be similar in India and Europe.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with minimum age of 18 years.
- •Patients implanted with study device and the hospital stay to a maximum of first seven days post index procedure.
- •Patients or Legally Acceptable Representative (LAR)/Impartial Witness understand study requirements and willing to provide written informed consent and willing to comply to study requirements.
排除标准
- •Patient with known hypersensitivity or idiosyncratic reaction to a) Sirolimus or its derivatives.
- •b) Antiplatelet/anticoagulant drugs.
- •c) L605 CrCo alloy.
- •d) Biodegradable polymers Poly(L-Lactide), 50:50 Poly (D,L-lactide-coglycolide).
- •Patient with terminal illness with life expectancy less than 1 year.
- •Patient with history of Cardiovascular Accident (CVA) within last 3 months.
- •Patient with history of diabetic haemorrhagenic retinopathy.
- •Patients with coronary stents implanted less than one calendar year ago.
- •Patient Implanted with other then the study devices DES or BMS.
- •Patients who are not willing to visit the same study site for 5-years of the follow-up period as per the study requirements.
- •Women of childbearing potential.
- •Any significant medical condition which in the Investigator’s opinion may interfere with the patient’s optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding.
- •Currently participating in another investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow up.
结局指标
主要结局
Incidence of Major Adverse
时间窗: 1, 6, 12 months.
Cardiac Events (MACE) as
时间窗: 1, 6, 12 months.
composite of cardiac-death,
时间窗: 1, 6, 12 months.
myocardial infarction (MI),
时间窗: 1, 6, 12 months.
target lesion revascularization
时间窗: 1, 6, 12 months.
(TLR) and target vessel
时间窗: 1, 6, 12 months.
revascularization (TVR), in the
时间窗: 1, 6, 12 months.
1-, 6- and 12-month clinical
时间窗: 1, 6, 12 months.
follow-up of post implantation
时间窗: 1, 6, 12 months.
index procedure
时间窗: 1, 6, 12 months.
• Patient Oriented Composite
时间窗: 1, 6, 12 months.
Endpoint (PoCE) (primary) -
时间窗: 1, 6, 12 months.
defined as the composite of allcause death, any MI (Nontarget vessel), any stroke, Stent
时间窗: 1, 6, 12 months.
Thrombosis (ST), Stent
时间窗: 1, 6, 12 months.
Restenosis, Non-TLR, Non TVR, Target Lesion Failure
时间窗: 1, 6, 12 months.
(TLF) at 1-, 6- and 12-months
时间窗: 1, 6, 12 months.
clinical follow-up of post
时间窗: 1, 6, 12 months.
implantation index procedure
时间窗: 1, 6, 12 months.
次要结局
- Incidence of Major Adverse(Cardiac Events (MACE) as)
研究者
Dr Jay Shah
Star Hospital