Clinical trial NCT02753998: Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
Official title: Paclitaxel-coated Balloon Angioplasty Versus Standard Angioplasty for the Treatment of Stenosis of Arteriovenous Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angioplasty
Stenosis of Arteriovenous Fistula
Keywords: Stenosis of arteriovenous fistula
Angioplasty
Paclitaxel-Coated Balloon Angioplasty
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Bard Peripheral Vascular, Inc.
First posted: 2016-04-28
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, man or woman.
* Chronic Hemodialysis.
* Native autologous arteriovenous fistula (AVF).
* AVF used at least once for hemodialysis.
* Preoperative flow measurement of AVF performed by Doppler.
* Length of the stenosis \<120 mm.
* Outer diameter of the target vein \<12mm.
* Hemodynamically significant Stenosis on AV fistula, defined according to international recommendations with the following two criteria:

  1. stenosis\> 50% by Doppler or angiography,
  2. presenting at least one of the following :

     1. increased venous pressure during dialysis (venous pressure \> 150 mmHg when blood flow measured at 200-225 ml / min, or venous pressure \> 230 mmHg when blood flow measured at 400 ml / min);
     2. disappearance of thrill of AV fistula;
     3. increasing hemostasis time at the end of dialysis (\> 20 minutes or increase by \>=50% from usual hemostasis time);
     4. recirculation rate \> 20%;
     5. flow of AVF \< 500 ml / min responsible for a reduction of the flow of the dialysis circuit.
* Only one stenosis with significant impact hemodynamically.
* Signed informed consent.
* Patient has a health insurance.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Severe allergy to iodinated contrast agents, or to heparin, or to paclitaxel.
* Anastomotic stenosis involving the afferent artery.
* Multiple hemodynamically significant stenoses.
* Hemodynamically significant central venous stenosis.
* Stent already in place in treated vascular site.
* Diameter of the vein immediately upstream of stenosis greater than the maximum diameter of active balloon.
* AVF in lower limb.
* Coagulation disorder (outside of VKA use).
* Active infection.
* Inability to comply with the protocol requirements.
* Life expectancy less than 1 year due to progressive disease (neoplasia, severe organ failure).
* Follow-up expected to be difficult.
* Patient under guardianship.

Primary outcomes:
measure: Cumulated incidence of loss of primary patency of AVF
timeFrame: At 6 months
Secondary outcomes:
measure: Cumulated incidence of primary patency loss of the target lesion
timeFrame: At 3 months and 12 months
measure: Cumulated incidence of restenosis > 50% at the site of angioplasty
timeFrame: At 3, 6 and 12 months
measure: Cumulated incidence of deteriorating flow rate
timeFrame: At 3, 6 and 12 months
measure: Cumulated incidence of patients with a flow rate < 500 ml / min
timeFrame: At 3, 6 and 12 months
measure: Cumulative rate of thrombosis
timeFrame: At 3, 6 and 12 months
measure: Time period before event's appearance
timeFrame: At 12 months
measure: Cumulated incidence of adverse event (AE)
timeFrame: At 12 months
measure: Medical costs
timeFrame: At 3, 6 and 12 months
measure: Cumulative incidence of cardiovascular serious adverse event (SAE)
timeFrame: At 12 months
measure: Cumulative incidence of death
timeFrame: At 12 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service chirurgie vasculaire, Hôpital Ambroise Paré
state: Hauts-de-Seine
Study officials:
affiliation: Service chirurgie vasculaire, Hôpital Ambroise Paré
name: Raphaël Coscas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: