A Retrospective, Open-label, Non-randomized Post-Market Clinical Follow up study to assess the safety and performance of the Relisys Post-dilatation catheters in human subjects who underwent coronary angioplasty.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- To assess the safety of Relisys Post-dilatation
研究概览
简要总结
This study is a retrospective, non-randomized, open-label, single-arm post-marketing clinical follow-up study. The evaluation exhibits the safety and performance of the Relisys post-dilatation catheters in human subjects who underwent coronary angioplasty. The study is designed to collect 5-year clinical data from patients from a single center where the device was consistently placed. The data from January 2019 to December 2023 on patients who underwent coronary angioplasty in the selected center and, during the procedure, Relisys post-dilatation catheters of different brands like VEDA+R NC, JADE-NC, PEARL-NC, etc. that were used in patients will be collected. This retrospective data will be analyzed to assess the safety and performance of the device.
研究设计
- 研究类型
- Observational
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.The patient must be 18 years of age or older, irrespective of gender.
- •2.Subjects who underwent treatment with stenotic lesions in coronary arteries or bypass graft stenosis for percutaneous coronary intervention (PCI).
- •3.The patient had single or multiple vessel coronary artery disease and clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and, or a positive functional study.
- •4.Underwent treatment with Relisys post-dilatation catheters during the period Jan2019–Dec
- •5.The subject must have denovo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention.
- •6.A maximum of three lesions, including at least one target lesion, in up to two coronary arteries.
- •7.Target and non-target lesions must be in different coronary arteries or bypass grafts.
排除标准
- •1.Pregnant Female.
- •2.Presence of any known life-threatening non-cardiac (major or progressive) disease that will limit the patients life expectancy.
- •3.Documented evidence of significant renal dysfunction dysfunction(serum creatinine less than 3.0mg per dl) or on any form of dialysis.
- •4.Psychiatric or behavioral disease, including known alcohol or drug abuse (continued use of alcohol, illegal drugs, or the misuse of prescription or over-the-counter drugs with negative physical or psychological consequences).
- •5.Subjects who have known hypersensitivity to device materials.
- •6.The patient has any other concurrent conditions that, in the opinion of the investigator, may compromise patient safety, privacy, and study objectives.
结局指标
主要结局
To assess the safety of Relisys Post-dilatation
时间窗: Baseline
catheter in patients.
时间窗: Baseline
次要结局
- To assess the performance of Relisys Post-dilatation(catheter in patients.)
研究者
Dr Sanjay R Tarlekar
Sushrusha Heart Care Center & Multi Speciality Hospital