Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF) Clinical trial medical device identification number: AMG0102 - Evaluation of clinical utility of NF-kB Decoy Oligo coated PTA balloon catheter for arteriovenous fistula stenosis in hemodialysis shunts (AVF) Clinical trial medical device identification number: AMG0102

AnGes MG, Inc.0 个研究点目标入组 177 人开始时间: 2012年6月5日最近更新: 2023年10月17日

适应症

试验速览

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•Not included if any of the below applies. 1.Stenosis lesion is calcified. 2.Underlying disease for dialysis is SLE nephritis, renal failure associated with congenital metabolic disorders or myeloma, or patient who returns to dialysis after renal transplantation. 3.There is a stenosis within 30mm to the both sides, calcified lesion or varicose located of targeted lesion. 4.Existing stent within the lesion. 5.The targeted stenosis site has been treated with cutting-balloon, etc., & determined as unstable for treatment with AMG0102. 6.Indication to surgical procedure. 7.50% or more central venous stenosis. 8.Cardiac dysfunction by intervention. 9.Unwilling for scheduled follow up. 10.Prognosis as less than 12 months. 11.Pregnant or nursing woman, etc. 12.Dementia 13.Diagnosed malignancy. 14.Allergy or resistance to Heparin. 15.History of life-threatening reaction to contrast medium. 16.Enrolled in another investigational study & follow up evaluation not completed. 17.Systemic infection within 24 hours. 18.Unstable for the study

发起方

AnGes MG, Inc.