Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures(Xres5 image processing)

Philips Medical Systems Nederland B.V.0 个研究点目标入组 330 人开始时间: 待定最近更新: 2024年6月11日

试验速览

暂无简介。

•Subject will be undergoing an elective coronary catheterization.
•For phase la, lc, Id and 2/3: both patients undergoing diagnostic and interventional procedures can be included.
•For phases 1b, only patients undergoing PCI will be included.
•Subject is 18 years of age or older, or of legal age to give informed consent per national law.

•Subject with contrast allergies
•Subject with severe kidney disease (e-GFR<60* by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
•Subject participates in a potentially confounding drug or device trial during the course of the study.
•Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
•Subject with overt hyperthyroidism
•*for phase Id, patients with an e-GFR between 30 and 60 can also be included. In that stage of the study the Xres5 cine EPXs have already been fine-tuned. Indicating that the risk of, or the need for, an additional run, and thereby a potential increase in contrast medium exposure has been eliminated. Furthermore, as fluoroscopy is not meant for diagnosis it is rarely used in combination with contrast administration. Any dissatisfaction with Xres5 fluoroscopy IQ, requiring additional fluoroscopy with Clarity fluoroscopy, will not involve contrast medium administration. For phase 2/3, patients with an e-GFR30-60 can also be included if the physician chooses to use the reduced iodine Xres5 EPX. In that setting the patient could actually benefit from participation as the total contrast load would be reduced.

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