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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Proportion of patients with primary patency of AVF [ Time Frame: At 6 months ]

Double-blind comparison of the proportion of primary patency at 6 months after treatment of stenosis of AVF by conventional angioplasty + additional angioplasty.

Primary patency is defined as absence of reintervention for stenosis at initial angioplasty site.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients with primary patency of AVF [ Time Frame: At 3 months and 12 months ]

    Double-blind comparison of the proportion of primary patency at 3 and 12 months after treatment of stenosis of AVF.

    Primary patency is defined as absence of reintervention for stenosis at initial angioplasty site.

  • Rate of restenosis > 50% at the site of angioplasty [ Time Frame: At 3, 6 and 12 months ]
    Proportion of patients with at least one restenosis of AVF > 50% at angioplasty site.
  • Proportion of patients deteriorating back to preoperative flow of arteriovenous fistula [ Time Frame: At 3, 6 and 12 months ]
    Proportion of patients with arteriovenous fistula returning to preoperative flow rate (defined as a flow rate within 20% of preoperative flow rate).
  • Proportion of patients with a flow rate < 500 ml / min [ Time Frame: At 3, 6 and 12 months ]
    Proportion of patients with a flow rate < 500 ml / min after treatments of stenosis.
  • Cumulative rate of thrombosis [ Time Frame: At 3, 6 and 12 months ]
    Compare at 3, 6 and 12 months the cumulative rate of thrombosis.
  • Medical costs [ Time Frame: At 3, 6 and 12 months ]

    Compare at 3, 6 and 12 months the costs of treatments of AVF

    The costs will include direct medical care, initial treatments, monitoring, diagnosis and treatment of complications.

  • Proportion of patients with at least one thrombosis of AVF [ Time Frame: At 3, 6 and 12 months ]
    Proportion of patients with at least one thrombosis of AVF at 3, 6 and 12 month.


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: April 25, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: January 10, 2017
Last Verified: September 2016