CTRI/2022/07/044472进行中（未招募）不适用
A prospective, open-labelled, multicentre, observational registry of ISAR SUMMIT in CAD patients undergoing PCI in real world indian population (TRANSEVER REGISTRY)
Dr Praveen Chandra31 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年7月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 31
- 主要终点
- Cardiac Death
研究概览
简要总结
It is a Prospective ,Observational, Multicentre, registry study to evaluate safety and performance of Polymer Free Everolimus Eluting Coronary Stent System In Real World Population.1000 patients will be enrollrd from 33 sites in India. The patients will be followed up till 1 year post index procedure to assess clinical status and major clinical events.
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
- •Male or female patient with age > 18 Years
- •Patients with coronary artery disease undergoing percutaneous coronary intervention(PCI) with ISAR Summit Polymer Free Everolimus Eluting Coronary Stent System
- •Patients or legal guardian who understands the study requirements and can provide informed consent in writing.
排除标准
- •Concurrent participation in another clinical trial that involves an investigational drug or device
- •Participant is pregnant or nursing an infant or child or planning to come pregnant while in the study
- •Concurrent medical condition with a life expectancy of less than 12 months
- •Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel or ticagrelor, Everolimus or similar drugs,or any other analogue or derivative, cobalt, chromium or contrast media.
结局指标
主要结局
Cardiac Death
时间窗: 1 Year
Target Vessel failure related Myocardial Infarction (TV- MI)
时间窗: 1 Year
Clinically driven Target Lesion Revascularization (TLR)
时间窗: 1 Year
次要结局
- Patient oriented composite (PoCE) defined as the composite of all- cause death,(any MI, any stroke and any Revascularization))
研究者
研究点 (31)
Loading locations...
相似试验
Unknown
不适用
A Prospective, Single-arm, Multi-centre, Observational, Real World RegistryAngina PectorisNCT02901353Meril Life Sciences Pvt. Ltd.400
尚未招募
Unknown
To evaluate the Safety and Performance of Intra-Articular Hyaluronic Acid (HA)(BIOVISC ORTHO) in Patients with wrist/elbow/shoulder/Hip joint disorder(s)CTRI/2025/05/086494BIOTECH VISION CARE PVT. LTD92
招募中
不适用
The Vesalio NeVa Stent Retriever Registry Study for Treatment of Large Vessel Occlusion StrokesAcute Ischemic StrokeNCT03926988Vesalio400
已完成
不适用
An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line TherapyNon-Squamous Non-Small Cell Lung CancerNCT01664533Hoffmann-La Roche57
已完成
不适用
StimRouter Registry Clinical ProtocolChronic PainNervous System DiseasesPeripheral Nervous System DiseasesPeripheral Nervous System ProblemPeripheral Nerve InjuriesPeripheral NervousPeripheral NeuropathyNCT03913689Bioness Inc62