A Prospective Clinical Study to Evaluate the Safety and Performance of PTCA Balloon Dilatation Catheters in Patients Undergoing Coronary Angioplasty.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- evaluation on safety of the PTCA Balloon Dilatation Catheter in achieving successful balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis.
研究概览
简要总结
Type of Study:The study will be a prospective, interventional, single-centric, non-randomized and open label study.
Description of the investigational device-
The Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange system. The distal section of this catheter consists of a balloon and dual lumen shafts (co-axial). The outer lumen is used for inflation and deflation of the balloon with contrast medium diluted with saline solution. The inner lumen (the guidewire lumen; from the distal tip to the guidewire port) is for inserting a compatible guidewire to facilitate advancing the catheter through the stenotic lesion or stent to be dilated. The proximal section is a single lumen shaft with a single luer port hub for connecting an inflation/deflation device. Inside the balloon, two radiopaque markers which indicate the working length of the balloon, are placed to guide the physician for positioning the balloon properly in the targeted lesion under fluoroscopy. POLYMED PTCA Balloon Dilatation Catheter is available in various balloon sizes by its diameter and length at recommended inflation pressures (Nominal pressure). Upon inflation, the balloon diameter varies according to the inflating pressure. The balloon compliance chart for PTCA Balloon Dilatation Catheter is provided at the end of this Instructions for Use. In the sterilization package, the device is equipped with protective materials: a balloon protective tube and a stylet, which are to be removed before use. The catheter’s distal tip is tapered to facilitate advancing into the stenotic lesion or stent. The catheter’s outer surface is partially coated with hydrophilic polymer to generate lubricity when wet.
Study Design:This is a prospective, single-center, interventional clinical investigation designed to assess the safety and performance of the PTCA Balloon Dilatation Catheter in angioplasty, enrolling 74 subjects.
Eligible subjects will provide informed consent, and baseline clinical data will be recorded. Pre-procedure assessments will include vital signs, medical history, and vascular access evaluation.
Eligible subjects will then proceed to angioplasty using the investigational PTCA Balloon Dilatation Catheter. Under fluoroscopic guidance, a compatible guidewire will be introduced across the lesion, followed by advancement of the balloon catheter to the target site. The balloon will be inflated to the appropriate nominal or rated burst pressure as per the lesion characteristics and deflated after sufficient expansion. In some cases, the catheter may also be used for post-dilatation following stent placement, if deemed necessary by the treating physician. Operator feedback on device performance, such as trackability, crossing success, and inflation/deflation behaviour, will be recorded in real time.
Follow-up visits will be conducted on Day 7 and Day 30. Data from each visit will be collected and recorded in CRFs and analysed accordingly.
Safety and performance endpoints will be evaluated using descriptive statistics. The investigator will assess and categorize all adverse events based on their severity and relationship to the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects aged 18 years and above 2.Subjects diagnosed with coronary artery disease requiring percutaneous coronary intervention (PCI).
- •3.No prior stenting at the target lesion within the last 6 months.
- •4.Subjects with suitable vascular anatomy for catheter placement.
- •5.Ability to provide written informed consent.
排除标准
- •1.Known allergy to contrast media or balloon catheter materials.
- •2.Subjects with an unprotected left main coronary artery.
- •3.Subjects with coronary artery spasm in the absence of a significant stenosis.
- •4.Bleeding diathesis or contraindication to anticoagulation.
- •5.Pregnant or lactating women or women of childbearing potential not using adequate contraception.
结局指标
主要结局
evaluation on safety of the PTCA Balloon Dilatation Catheter in achieving successful balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis.
时间窗: Follow-ups will be conducted on Day 7 and Day 30, data collected at each follow-up will be assessed, recorded, and analysed to evaluate safety and performance.
次要结局
- To assess the device performance characteristics including balloon deliverability, trackability, crossing profile, inflation/deflation times, balloon integrity, & compatibility with guidewires & stents during the procedure.(Follow-ups will be conducted on Day 7 & Day 30, data collected at each follow-up will be assessed, recorded, & analysed to evaluate safety & performance.)
研究者
Dr N Rajasekar
Sudha Hospitals