A Prospective, Interventional, Single-Center, Single-Arm Clinical Investigation to Evaluate the Safety and Effectiveness of the Newtech Balloon Dilatation Catheter for Percutaneous Transluminal Coronary Angioplasty (PTCA) in Patients with Coronary Artery Stenosis.
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
- To evaluate the safety and performance of the Newtech Balloon Dilatation Catheter in achieving successful dilatation of stenotic lesions in coronary arteries or bypass grafts in patients with myocardial ischemia.
研究概览
简要总结
This is a prospective, interventional, multi-center, single-arm, open-label clinical investigation designed to evaluate the clinical safety and performance of the Newtech Balloon Dilatation Catheter in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) for the treatment of coronary artery disease. The study population will include patients aged 18 years and above, diagnosed with significant stenosis in native coronary arteries or coronary artery bypass grafts, who are scheduled for elective PTCA and meet all 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
- •Adults aged 18 years or older male and female Diagnosis of coronary artery disease requiring elective percutaneous transluminal coronary angioplasty PTCA in a native coronary artery or coronary artery bypass graft.
- •Presence of a significant stenotic lesion of 70 percent or more in one or more coronary vessels suitable for balloon angioplasty using the investigational device.
- •Target lesion is angiographically accessible and crossable with a balloon catheter.
- •Reference vessel diameter and lesion characteristics are within the available balloon size range eg 2.25 mm to 4.0 mm specified in the device IFU.
- •Subject is eligible to undergo angiography and interventional procedures under local anesthesia.
- •Subject or legally authorized representative has provided written informed consent prior to enrollment.
- •Willing and able to comply with the protocol-required follow-up schedule.
排除标准
- •Unprotected left main coronary artery disease as noted in the IFU under contraindications.
- •Presence of coronary artery spasm in the absence of significant stenosis, per IFU contraindications.
- •Acute ST-elevation myocardial infarction STEMI requiring emergency intervention.
- •Presence of chronic total occlusion or heavily calcified lesions not suitable for balloon angioplasty alone.
- •Known bleeding disorders or abnormal blood clotting profiles, such as an INR greater than 1.5 or a platelet count less than 100,000 per cubic millimeter.
- •Severe left ventricular dysfunction with an ejection fraction less than 30 percent or hemodynamic instability.
- •History of hypersensitivity or contraindication to contrast media, heparin, or balloon materials.
- •Participation in another investigational device or drug study within the last 30 days.
- •Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.
- •Life expectancy of less than 90 days due to non-cardiac health conditions, such as advanced cancer.
结局指标
主要结局
To evaluate the safety and performance of the Newtech Balloon Dilatation Catheter in achieving successful dilatation of stenotic lesions in coronary arteries or bypass grafts in patients with myocardial ischemia.
时间窗: Pre-operative, Operative Day, Day2, Day7
To assess the procedural success rate, defined as successful delivery, inflation, and withdrawal of the catheter without device-related complications.
时间窗: Pre-operative, Operative Day, Day2, Day7
次要结局
- To evaluate the incidence of device-related adverse events during immediately after the procedure eg vessel dissection perforation acute occlusion or spasm(To assess angiographic improvement post-procedure such as restoration of target vessel patency improved coronary blood flow.)
研究者
Dr Vikas Gupta
Heart and General Hospital Jaipur