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

Philips0 个研究点目标入组 305 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。

•Contrast allergies
•Severe kidney disease (e-GFR < 60* by Modification of Diet in Renal Disease
•(MDRD)/Cockcroft Gault clearance formula and/or upon decision by
•investigator/treating physician)
•Participation in a potentially confounding drug or device trial during the
•course of the study.
•Exclusion criteria according to national law (e.g. age, pregnant woman,
•breast feeding woman)
•Overt hyperthyroidism, *for phase 1d, 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-GFR 30-60 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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