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

NCT ID: NCT02753998

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2022-03-31

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.

Conditions

Angioplasty; Stenosis of Arteriovenous Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional angioplasty + paclitaxel-coated balloon

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

Group Type: EXPERIMENTAL

Additional angioplasty with paclitaxel-coated balloon

Intervention Type: COMBINATION_PRODUCT

Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty

Conventional angioplasty

Intervention Type: PROCEDURE

Conventional angioplasty + placebo balloon

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

Group Type: PLACEBO_COMPARATOR

Additional angioplasty with placebo balloon

Intervention Type: COMBINATION_PRODUCT

Additional angioplasty with placebo balloon after conventional angioplasty

Conventional angioplasty

Intervention Type: PROCEDURE

Interventions

Additional angioplasty with paclitaxel-coated balloon

Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty

Intervention Type: COMBINATION_PRODUCT

Additional angioplasty with placebo balloon

Additional angioplasty with placebo balloon after conventional angioplasty

Intervention Type: COMBINATION_PRODUCT

Conventional angioplasty

Intervention Type: PROCEDURE

Other Intervention Names

Lutonix® 035 balloon; ClearPAC Omega® balloon

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bard Peripheral Vascular, Inc.

INDUSTRY

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphaël Coscas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Service chirurgie vasculaire, Hôpital Ambroise Paré

Locations

Service chirurgie vasculaire, Hôpital Ambroise Paré

Boulogne-Billancourt, Hauts-de-Seine, France

Countries

France

Other Identifiers

P150908

Identifier Type: -

Identifier Source: org_study_id