Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial (ACADEMIC)
Stenosis of Arteriovenous Dialysis Fistula
About this trial
This is an interventional treatment trial for Stenosis of Arteriovenous Dialysis Fistula focused on measuring non-maturing arteriovenous fistula, stenosis of arteriovenous fistula, drug-eluting balloon
Eligibility Criteria
Inclusion Criteria:
Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
- Non-maturing on physical examination, or
- Failed initial cannulation, or
- Failure to achieve prescribed dialysis within prescribed time frame.
- Stenosis (>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
- Successful guidewire crossing of target lesion.
- >= 21 years old.
- Informed consent given.
- Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.
Exclusion Criteria:
- Thrombosed non-maturing AVF
- Target lesion is longer than 8 cm
- Previous endovascular therapy for non-maturation of the trial AVF
- Baseline systolic blood pressure less than 100 mmHg
- Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
- Coagulopathy (prothrombin time or activated partial thromboplastin time >1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
- Thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion
- Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication
- Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel
- Acute infection over proposed puncture site
- Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
- Men who are planning on fathering children during the study.
- Participant with medical conditions which in the opinion of the investigator may cause non-compliance with protocol.
- Currently participating in an investigational drug, biologic or device trial that may have an impact on the AVF or previous enrollment in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Drug-eluting Balloon Angioplasty (DEBA)
Conventional Balloon Angioplasty (CBA)
After predilatation of the target lesion with conventional balloon angioplasty, a drug-eluting balloon will be inflated to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.
The target lesion will be dilated with a conventional angioplasty balloon to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute.