MedTrace Logo

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

NCT02753998 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2022-03-22

No results posted yet for this study

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.

Conditions

  • Angioplasty
  • Stenosis of Arteriovenous Fistula

Interventions

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

Sponsors & Collaborators

  • Bard Peripheral Vascular, Inc.

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Raphaël Coscas, MD, PhD · Service chirurgie vasculaire, Hôpital Ambroise Paré

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2022-02-28
Completion
2022-03-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753998 on ClinicalTrials.gov