A prospective open label randomized clinical study to evaluate the safety and effectiveness of the NICAST polyurethane vascular access graft

icast Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Candidates for implantattion of a prosthetic vascular access graft for haemodialysis access.these are patients who are not eligible for creation of native fistulae according to the standard of care in the medical center 2. Male or female subjects 18 year or older of any race 3. Subjects willing to participate as evidenced by signing the written informed consent

•Subjects with any medical condition that would expose the subject to increased risk by the investigational device or procedure according to the investigator's decision Subjects with elevated WBC counts Subjects with bilirubin level >3mg/dl Concurrent existence of another vascular access graft in the same limb Subjects with known hypersensitivity or allergy to polyurethane products or any other contraindication to implantation of a polyurethane graft Female subjects who are pregnant or lactating Subjects participating in any other clinical study at the same time

发起方

icast Ltd