Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
Summary
The primary objective of this double-blind study is to compare the frequency of primary patency at 6 months in patients with stenosis of arteriovenous fistula (AVF) treated either by conventional angioplasty + angioplasty with balloon impregnated with paclitaxel or by conventional angioplasty + angioplasty with placebo balloon (balloon not impregnated with paclitaxel). The other objectives of the study are: 1. To compare the frequency of primary patency at 3 months and 12 months. 2. To compare the rate of restenosis \> 50% at the site of angioplasty at 3, 6 and 12 months. 3. To compare, at 3, 6 and 12 months, the proportion of patients with arteriovenous fistula deteriorating back to preoperative flow rate (within 20% of preoperative flow rate). 4. To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate \< 500 ml / min. 5. To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis. 6. To compare, at 3, 6 and 12 months, the medical costs related to direct medical care, initial treatments, monitoring, diagnosis and treatments of complications.
Timeline
- Start
- 2016-12
- Primary completion
- 2022-02
- Completion
- 2022-03
Outcome
Missed primary endpoint
paper there was no significant difference between the groups regarding primary patency loss at 6 months PMID 42379345 ↗
paper p = .09; hazard ratio = 0.62 [95% confidence interval {CI} 0.36 - 1.07]. PMID 42379345 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | — | — |
Indications
No indication recorded.