A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Assess the Safety and Performance of the Newtech Sirolimus-Eluting Coronary Stent System in Patients with Symptomatic Ischemic Heart Disease Undergoing Percutaneous Transluminal Coronary Angioplasty (PTCA).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate the safety, performance, and procedural success of the Newtech Sirolimus-Eluting Coronary Stent System in achieving successful revascularization of de novo coronary artery lesions in CAD patients undergoing PCI without major device-related complications.
研究概览
简要总结
This is a prospective, interventional, Single-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Sirolimus-Eluting Coronary Stent System in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). The study will include approximately 90 patients presenting with de novo atherosclerotic lesions in native coronary arteries who are eligible for stent placement in accordance with standard interventional cardiology practice. Subjects will be enrolled after providing written informed consent and undergoing screening as per the predefined inclusion and exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 18 years or older male or female 2.Diagnosis of coronary artery disease CAD with de novo stenotic lesions in native coronary arteries requiring percutaneous coronary intervention PCI 3.Target lesion is accessible and can be crossed with a guidewire and balloon catheter 4.Subject is clinically stable and eligible to undergo angiography and PCI under local anaesthesia 5.Subject or legally authorized representative has provided written informed consent prior to participation 6.Subject is willing and able to comply with all protocol-required follow-up visits and assessments.
排除标准
- •1.Patients who are not candidates for coronary bypass surgery.
- •3.Patients with angiographic evidence of existing thrombus at the intended lesion site.
- •4.Patients with known hypersensitivity or allergy to cobalt-chromium L605 alloy.
- •5.Patients with a contraindication to antiplatelet or anticoagulant therapy including Recent major surgery, Obstetric delivery Organ biopsy Active gastrointestinal bleeding History of cerebrovascular accident CVA Diabetic retinopathy any other condition associated with increased bleeding risk 6.Pregnant women or women of childbearing potential 7.Patients who have experienced a recent acute myocardial infarction within the past 7 days 8.Patients with diffuse coronary artery disease defined as long segments of abnormal vessel without normal interposed segment 9Transplant patients.
结局指标
主要结局
To evaluate the safety, performance, and procedural success of the Newtech Sirolimus-Eluting Coronary Stent System in achieving successful revascularization of de novo coronary artery lesions in CAD patients undergoing PCI without major device-related complications.
时间窗: Procedure Day, Post-Procedure,Day30, Day90, Day180
次要结局
- To monitor early device-related adverse events assess angiographic performance using QCA during the procedure follow-up evaluate handling characteristics, including visibility tracking balloon performance system compatibility ensure adherence to the Instructions for Use regarding patient selection device application storage conditions
研究者
Dr Vikas Gupta
Heart and General Hospital Jaipur