Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Stenosis of Arteriovenous Dialysis Fistula
- Sponsor
- Singapore General Hospital
- Enrollment
- 124
- Primary Endpoint
- Fistula used successfully for haemodialysis (FUSH)
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
Detailed Description
This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow). Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment. If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon. If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel), followed by 5 months of aspirin. The duration of the study is 12 months. Follow up visits include: 1. Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation. 2. At 3 months after intervention to assess primary outcome. 3. At 6 months after intervention for a fistulogram 4. At 12 months after intervention for study closure.
Investigators
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
Outcomes
Primary Outcomes
Fistula used successfully for haemodialysis (FUSH)
Time Frame: 3 month
FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.
Secondary Outcomes
- Target lesion anatomic success(At the end of index procedure)
- Time from intervention to first successful haemodialysis with two-needle cannulation(Up to 12 months)
- Target lesion percent stenosis at 6-month fistulogram(At 6 months)
- Target lesion restenosis rate at 6-month fistulogram(At 6 months)
- Number of repeat interventions to target lesion at 6 months(At 6 months)
- Number of repeat interventions to target lesion at 12 months(At 12 months)
- Number of repeat interventions to access circuit at 6 months(At 6 months)
- Number of repeat interventions to access circuit at 12 months(At 12 months)
- Post intervention target lesion patency(Up to 12 months)
- Post intervention access circuit primary patency(Up to 12 months)
- Post intervention access circuit assisted primary patency(Up to 12 months)
- Post-intervention access circuit secondary patency(Up to 12 months)
- Complication rates(At 12 months)