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

NCT02753998 | Completed Phase 3 DMC

• 1 other identifier: P150908
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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. 1.To compare the frequency of primary patency at 3 months and 12 months.
2. 2.To compare the rate of restenosis \> 50% at the site of angioplasty at 3, 6 and 12 months.
3. 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. 4.To compare, at 3, 6 and 12 months, the proportion of AVF with a flow rate \< 500 ml / min.
5. 5.To compare, at 3, 6 and 12 months, the cumulative rate of thrombosis.
6. 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.

Conditions

Angioplasty; Stenosis of Arteriovenous Fistula

Keywords

Stenosis of arteriovenous fistula; Angioplasty; Paclitaxel-Coated Balloon Angioplasty

Outcome Measures

Primary Outcomes (1)

• Cumulated incidence of loss of primary patency of AVF

  Double-blind comparison of cumulated incidence of primary patency at 6 months after treatment of stenosis of AVF by conventional angioplasty + additional angioplasty. Cumulated incidence of primary patency loss of AVF at 6 months post procedure.

  At 6 months

Secondary Outcomes (10)

• Cumulated incidence of primary patency loss of the target lesion

  At 3 months and 12 months

• Cumulated incidence of restenosis > 50% at the site of angioplasty

  At 3, 6 and 12 months

• Cumulated incidence of deteriorating flow rate

  At 3, 6 and 12 months

• Cumulated incidence of patients with a flow rate < 500 ml / min

  At 3, 6 and 12 months

• Cumulative rate of thrombosis

  At 3, 6 and 12 months

Study Arms (2)

Conventional angioplasty + paclitaxel-coated balloon

EXPERIMENTAL

Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with paclitaxel-coated balloon

Combination Product: Additional angioplasty with paclitaxel-coated balloon; Procedure: Conventional angioplasty

Conventional angioplasty + placebo balloon

PLACEBO COMPARATOR

Treatment of stenosis of AVF by conventional angioplasty + 1 minute additional angioplasty with placebo balloon.

Combination Product: Additional angioplasty with placebo balloon; Procedure: Conventional angioplasty

Interventions

Additional angioplasty with paclitaxel-coated balloon COMBINATION_PRODUCT

Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty

Also known as: Lutonix® 035 balloon

Conventional angioplasty + paclitaxel-coated balloon

Additional angioplasty with placebo balloon COMBINATION_PRODUCT

Additional angioplasty with placebo balloon after conventional angioplasty

Also known as: ClearPAC Omega® balloon

Conventional angioplasty + placebo balloon

Conventional angioplasty PROCEDURE

Conventional angioplasty + paclitaxel-coated balloon; Conventional angioplasty + placebo balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• stenosis\> 50% by Doppler or angiography,
• presenting at least one of the following :
• 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);
• disappearance of thrill of AV fistula;
• increasing hemostasis time at the end of dialysis (\> 20 minutes or increase by \>=50% from usual hemostasis time);
• recirculation rate \> 20%;
• flow of AVF \< 500 ml / min responsible for a reduction of the flow of the dialysis circuit.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Bard Peripheral Vascular, Inc.: collaborator

Study Sites (1)

Service chirurgie vasculaire, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, 92100, France

Location

Study Officials

• Raphaël Coscas, MD, PhD

  Service chirurgie vasculaire, Hôpital Ambroise Paré

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 28, 2016
• Study Start: December 1, 2016
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)