A prospective, interventional, Single-centre, single-arm, clinical investigation to assess the safety and performance of the Newtech Guiding Catheter during diagnostic and interventional use in patients with Coronary and Peripheral Vascular Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Procedural Success Rate: Successful vascular access, device delivery, and contrast injection without catheter-related failure.
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 performance, safety, and usability of the Newtech Guiding Catheterduring real-world diagnostic and interventional cardiovascular procedures involving the coronary and peripheral vasculature. The study population will include patients who are scheduled to undergo elective or indicated percutaneous coronary or peripheral interventions and meet all study eligibility criteria. Subjects will be enrolled only after providing written informed consent, and the investigational guiding catheter will be used in accordance with the manufacturer’s Instructions for Use (IFU) and routine interventional protocols.
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 and female Subjects scheduled for diagnostic or interventional cardiovascular procedures eg angiography, PCI where the use of a guiding catheter is clinically indicated.
- •2.Subjects able to provide written informed consent before any study specific procedures.
- •4.Target vessel anatomy is appropriate for catheter navigation and guide placement based on pre-procedural imaging.
- •Willing and able to comply with protocol requirements, including a 7day follow-up.
排除标准
- •1.Known allergy or hypersensitivity to materials used in the guiding catheter eg polymer coating, EO sterilization residuals.
- •2.Severe peripheral vascular disease, tortuous anatomy, or calcified vessels that may compromise safe catheter introduction or tracking.
- •3.Participation in another investigational study within the last 30 days that may interfere with this investigation.
- •4.Active systemic infection or localized infection at the planned vascular access site.
- •5.Pregnant or breastfeeding women, unless the procedure is clinically necessary and ethically justified.
- •6.Subjects with known coagulation disorders or on anticoagulant therapy that poses increased procedural risk.
- •8.Life expectancy less than 30 days due to underlying non-cardiac illnesses.
结局指标
主要结局
Procedural Success Rate: Successful vascular access, device delivery, and contrast injection without catheter-related failure.
时间窗: Pre-operative, Operative, Day2, Day7
Device-Related Adverse Events (within 7 days): No major complications such as dissection, perforation, vasospasm, embolism, hematoma, or catheter malfunction.
时间窗: Pre-operative, Operative, Day2, Day7
次要结局
- 1.Usability Investigator feedback on insertion, navigation, torque control, kink resistance, visibility.(2.Technical Issues Any problems like flushing difficulty, incompatibility, or need for catheter replacement.)
研究者
Dr Vikas Gupta
Heart and General Hospital Jaipur