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. - NI

Relisys Medical Devices Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•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 2023.
•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.
•8.The target lesion(s) must have a diameter stenosis of greater than 70percentage by visual estimation and be amenable to percutaneous intervention.

•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.

发起方

Relisys Medical Devices Limited