NCT02753998

Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Experimental design: prospective randomized, double blind, multicenter controlled study, with 2 experimental arms. 12 centers will participate in France, targeting to enrol 150 patients in total. Each patient will undergo angiography at the beginning of the intervention in order to confirm the presence of only one stenosis, to assess the degree of stenosis and to evaluate the vascular diameter. All patients will first undergo angioplasty using standard balloons. thereafter, depending on randomization arm, an additional angioplasty will be performed during 1 minute with a paclitaxel impregnated balloon (active arm) or with a placebo balloon (placebo arm). The duration of inclusion is planned for 18 months. Each patient will have a 12-month follow-up.

Conditions

• Angioplasty
• Stenosis of Arteriovenous Fistula

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Additional angioplasty with paclitaxel-coated balloon	Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty
COMBINATION_PRODUCT	Additional angioplasty with placebo balloon	Additional angioplasty with placebo balloon after conventional angioplasty
PROCEDURE	Conventional angioplasty

Timeline

• Start date: 2016-12-01
• Primary completion: 2022-02-01
• Completion: 2022-03-01
• First posted: 2016-04-28
• Last updated: 2022-03-22

Locations

1 site across 1 country: France