Arteriovenous fistula stenosis in hemodialysis shunts
Conditions
Interventions
Percutaneous transluminal angioplasty (PTA)
NF-kB Decoy Oligo coated PTA balloon catheter
Sponsors
AnGes MG, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical criteria 1.20 years or older, provides written IC 2.Agree if not enrolled within 30 days after IC, another IC is needed. 3.Constructed AVF at least 4 weeks before IC & at least 3 successful HD. 4.Angiography or echo confirms a stenosis determined as targeted lesion & no surgical intervention before. 5.1 Stenosed lesion is of 50% or more stenosis rate and at least one of the below abnormalities is confirmed, and PTA is the best choice. i. Multiple occurrences of 180ml/min or less blood removal. ii. Increased in venous pressure by 50mmHg,or 150mmHg pressure persisted constantly. iii.Efficiency of dialysis by recirculation decreased by 10% or more. 6.The targeted stenosed lesion is 60mm or less in length. 7.In access circuit, no other stenosis 50% or more of stenosis rate exists within 30mm of both sides. If it exists, it must have been treated with PTA alone at least 30 days before IC with residual stenosis rate less than 30% and no complications & the stenosis rate of 30% or less. 8.Can visit for follow up. Angiographic inclusion criteria: The stenosis confirms 1 lesion,length 60mm or less & stenosis rate 50% or more.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of primary patency up to 36 weeks after intervention on the targeted venous stenosis site | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, primary patency rate, procedural success, anatomic success, clinical success, patency after repeated AMG0102 intervention | — |
Countries
Japan
Contacts
Public ContactKazuki Ide
AnGes MG Inc. Medical Device Clinical Development Department
Outcome results
None listed