A Prospective Clinical Investigation to Evaluate the Safety and Performance of a PTFE Guidewire in Angioplasty and Angiography
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- To assess the safety of the PTFE guidewire when used in angioplasty and angiography procedures.which focuses on the guidewire’s ability to minimize vessel trauma, enhance navigation particularly in complex anatomical regions and improve overall procedural outcomes.
研究概览
简要总结
Type of Study:The study will be a prospective, interventional, single-centric and open label study.
Description of the investigational device
PTFE Guidewire for percutaneous entry and guidance of catheters, the Diagnostic Guidewire complements our diagnostic catheter and catheter sheath introducer lines. Performance, endurance, and safety are built into each Guidewire with solid tensile strength to minimize the likelihood of stretching or fracturing. PTFE Guidewire have a Nitinol shaft. The shaft is either, PTFE and Heparin coated, or uncoated. Guide wire length, diameter, core configuration, flexibility type, tip configuration are all indicated on the product label.
Study Design:This is a prospective, single-center, interventional clinical investigation designed to evaluate the safety and performance of a PTFE guidewire when used in angioplasty and angiography procedures. A total of 49 patients will be enrolled in the study.
Following eligibility screening, informed consent will be obtained from all participants. Baseline clinical data, including vital signs, medical history, and vascular access status, will be collected during the pre-procedure assessments to establish each patient’s condition prior to device use.
During the angioplasty procedures, the PTFE guidewire will be introduced as per standard procedural protocols. The guidewire is designed to enable smooth and controlled navigation through the vascular system, reaching the site of arterial blockage. Its role is to provide critical support for the catheter, thereby facilitating effective vessel dilation and enhancing blood flow.
Similarly, in angiography procedures, the PTFE guidewire will be utilized in accordance with established clinical guidelines. It enables precise catheter placement at the target vascular location, assisting in the delivery of contrast media and contributing to the acquisition of accurate angiographic images.
Post-procedure monitoring will include observation for any AEs or SAEs. Patients will be followed up on Day 7 and Day 30, during which clinical data will be collected and recorded in the CRFs. Safety and performance endpoints will be assessed using descriptive statistical methods. All adverse events will be evaluated and classified by the investigator based on severity and relationship to the investigational 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 undergoing angiography or angiography or both requiring PTFE guide wire to support for the catheter, facilitating balloon inflation and stent placement.
- •3.Subjects with suitable vascular anatomy for PTFE guidewire navigation.
- •4.Ability to provide written informed consent.
排除标准
- •1.Subjects with severe vascular calcification or tortuosity that may prevent PTFE guidewire advancement.
- •2.Presence of active infection at the device insertion site.
- •3.Subjects with coagulopathy or on anticoagulant therapy, increasing the risk of bleeding.
- •4.History of vascular dissection or aneurysm at the planned access site.
- •5.Pregnant or lactating women.
- •6.Subjects requiring guide wire use in the coronary arteries or neurovasculature.
结局指标
主要结局
To assess the safety of the PTFE guidewire when used in angioplasty and angiography procedures.which focuses on the guidewire’s ability to minimize vessel trauma, enhance navigation particularly in complex anatomical regions and improve overall procedural outcomes.
时间窗: Follow-ups will be conducted on Days 7 and 30. Data collected at each follow-up will be assessed, recorded, and analyzed to evaluate safety and performance.
次要结局
- To evaluate the performance of the PTFE guidewire in effectively supporting the catheter & assisting with image.The study claims that PTFE guidewires are expected to demonstrate a low incidence of adverse events (AEs) & serious adverse events (SAEs). Additionally, their use is associated with improved procedural efficiency, enhanced device navigation, reduced risk of complications, better patient outcomes, & quicker recovery times.(Follow-ups will be conducted on Days 7 & 30. Data collected at each follow-up will be assessed, recorded, & analyzed to evaluate safety & performance.)
研究者
Dr N Rajasekar
Sudha Hospitals