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Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty (FAVABED)

Primary Purpose

Stenosis of Arteriovenous Dialysis Fistula

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Paclitaxel (Taxol) eluting angioplasty balloon
high-pressure angioplasty balloon
low-pressure balloon
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis of Arteriovenous Dialysis Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18,
  • Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days),
  • Native and efficient arteriovenous fistula > 3 months,
  • 3mm ≤ reference vein diameter ≤ 8 mm and stenosis length ≤ 10 cm (range of DEB diameters and lengths),
  • Absence of fistula thrombosis,
  • Possibility of crossing the stenosis with a guide wire,
  • Significant stenosis > 50% (in relation to the reference diameter) on the fistulogram,
  • Clinical diagnosis of imminent fistula dysfunction

    • pressure rise during dialysis
    • and/or puncture difficulties
    • and/or recirculation or poor extrarenal clearance
    • and/or decrease in vascular access flow
    • and/or increase in compression time after dialysis
  • Social security affiliation,
  • Receipt of free, informed, written consent.

Exclusion Criteria:

  • Multiple stenoses,
  • Goretex® graft prostheses
  • Systemic or local infection,
  • Known allergy to contrast agent or Paclitaxel.
  • Comorbidity not permitting long-term follow-up,
  • Life expectancy < 1 year,
  • Anticancer treatment (patients treated with chemotherapy for neoplasia),
  • Pregnant or breastfeeding woman,
  • Patients over 18 years of age who are under legal protection (conservatorship, trusteeship, guardianship), or deprived of freedom.

Sites / Locations

  • CHU Bordeaux
  • Centre Hospitalier Universitaire de Caen
  • Centre Hospitalier Universitaire de Clermont-FerrandRecruiting
  • Centre Hospitalier d'HaguenauRecruiting
  • APHM Hôpital la TimoneRecruiting
  • Centre Hospitalier Universitaire de MontpellierRecruiting
  • Hôpital Européen Georges PompidouRecruiting
  • Centre Hospitalier Universitaire de RENNESRecruiting
  • Centre Hospitalier Universitaire de ToulouseRecruiting
  • Clinique St Gatien de ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

"DEB" arm

"conventional angioplasty" arm

Arm Description

dilation by a high-pressure conventional angioplasty balloon (sized to fit the reference native vein diameter) until disappearance of the stenotic obstructive area and achievement of technical success (possibility of changing balloon size or dilation pressure) then dilation by a DEB.

dilation will be performed by a conventional high-pressure balloon until technical success is achieved (possibility of changing balloon size or dilation pressure), then by a sham balloon i.e a conventional low-pressure balloon (placebo)

Outcomes

Primary Outcome Measures

Number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty
assess the primary patency at 1 year after the dilatation of native AVF stenosis with "active" drug-eluting balloons (DEB) compared to conventional "plain" balloons, i.e to compare between the two groups the number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty.

Secondary Outcome Measures

primary patency at 6 months
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for primary patency at 6 months of the dilated stenosis
overall primary patency of the Arteriovenous Fistula at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for overall primary patency of the Arteriovenous Fistula at 1 year (patency including AVF dysfunction in relation to the initial dilated stenosis as well as stenoses distant from the initially treated site)
assisted primary patency of the dilated stenosis at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for assisted primary patency of the dilated stenosis at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions with new angioplasties on the initially dilated stenotic site (excluding de-obstruction for complete thrombosis)
secondary patency of the AVF at 1 year
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for secondary patency of the Arteriovenous Fistula at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions also including complete thrombosis de-obstruction procedures
The minimal diameter of the treated stenosis and the AVF flows
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for the minimal diameter of the treated stenosis (Late Luminal Loss) and the Arteriovenous Fistula flows (both criterion being evaluated by Doppler ultrasound and Transonic® after angioplasty, and at 6 months and 1 year follow-up).
Overall and cardiovascular survival
during analysis in sub-groups, the advantage of these Drug-Eluting Balloons for Overall and cardiovascular survival at 2 and 5 years for all patients and for subgroup of patients with symptomatic peripheral artery disease

Full Information

First Posted
September 20, 2016
Last Updated
March 27, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02913274
Brief Title
Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
Acronym
FAVABED
Official Title
Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisationand morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA. Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate but a poor 1-year patency rate. These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital. Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty. For the past few years, angioplasty balloons delivering anticancer drugs have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer molecule through the different layers of the vessel wall confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy. These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty. These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising. The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered. Patients that will be non-evaluable for the primary endpointwill be censored at the date of the latest news.
Detailed Description
Dysfunctions such as tight stenosis or thrombosis in haemodialysis vascular accesses are the leading cause of hospitalisation (20%) and morbidity in chronic haemodialysis patients incurring significant related costs estimated at over one billion dollars in the USA. Dysfunctions of these vascular accesses are generally treated by conventional angioplasty as this is the least invasive procedure, the alternative being revision surgery. Angioplasty uses an inflatable balloon of various diameters. Different types of angioplasty balloons may be needed to break fibrous venous stenosis, in particular high-pressure balloons (20 atm) or cutting balloons. These angioplasty procedures which are often painful during dilation have a high technical success rate (90-97%) but a poor 1-year patency rate, varying between 26 and 64% depending on the team and a mean rate estimated at 40% for the studies including the larger number of patients, some of whom requiring several procedures. These invasive repeated procedures impair the quality of life of these patients with end-stage renal disease who are on permanent dialysis or awaiting a kidney transplant and for whom vascular access patency is vital. Due to their traumatic effect on the vessel wall, these procedures induce cell proliferation processes that retrigger neointimal hyperplasia the very act of preserving the haemodialysis access is the key factor in development of a new stenosis and hence a vicious circle of stenosis-angioplasty. For the past few years, angioplasty balloons delivering anticancer drugs (Paclitaxel, Sirolimus, Everolimus) have been developed. These drugs, generally used in high doses for cancer chemotherapy, are released in small doses on the medical angioplasty devices. During inflation, the local release of the anticancer (antimitotic) molecule through the different layers of the vessel wall (Paclitaxel is lipophilic and hydrophobic) confers local antiproliferative action without the systemic toxic effects associated with high-dose chemotherapy. These medical devices have demonstrated their efficacy in terms of increase in primary and secondary patency rates on procedures such as coronary artery angioplasty, femoro-popliteal or sub-popliteal artery angioplasty (treatment of angina or lower limb arteriopathy). These drug-eluting balloons (DEBs) are also CE marked with the recommendation of being indicated for AVF anticancerangioplasties, but no randomised multi-centre clinical trial has proven their medical effectiveness, and in particular their contribution in terms of patency rate improvement. However, studies on animal models show significant results regarding efficacy against neointimal hyperplasia and the first single-centre clinical trials on a small sample size appear promising. The key assessment criterion is primary patency of the dilated stenosis at one year defined by patients efficaciously dialysed at one year without re-intervention on the dilated lesion after initial angioplasty. The delay of occurrence of dilation will be considered (censored criteria). Patients that will be non-evaluable for the primary endpoint (death, lost to follow-up…) will be censored at the date of the latest news.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis of Arteriovenous Dialysis Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
262 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"DEB" arm
Arm Type
Experimental
Arm Description
dilation by a high-pressure conventional angioplasty balloon (sized to fit the reference native vein diameter) until disappearance of the stenotic obstructive area and achievement of technical success (possibility of changing balloon size or dilation pressure) then dilation by a DEB.
Arm Title
"conventional angioplasty" arm
Arm Type
Active Comparator
Arm Description
dilation will be performed by a conventional high-pressure balloon until technical success is achieved (possibility of changing balloon size or dilation pressure), then by a sham balloon i.e a conventional low-pressure balloon (placebo)
Intervention Type
Device
Intervention Name(s)
Paclitaxel (Taxol) eluting angioplasty balloon
Other Intervention Name(s)
BARD, Lutonix® 035 and Lutonix®5F GeoAlign™
Intervention Description
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation by a DEB of the same size for 2 minutes.
Intervention Type
Device
Intervention Name(s)
high-pressure angioplasty balloon
Other Intervention Name(s)
BARD, Conquest®
Intervention Description
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation either by a shame balloon or by a DEB balloon of the same size for 2 minutes.
Intervention Type
Device
Intervention Name(s)
low-pressure balloon
Other Intervention Name(s)
BARD, Ultraverse®
Intervention Description
Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Thenn dilatation by a shame balloon i.e conventional low pression balloon of the same size for 2 minutes.
Primary Outcome Measure Information:
Title
Number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty
Description
assess the primary patency at 1 year after the dilatation of native AVF stenosis with "active" drug-eluting balloons (DEB) compared to conventional "plain" balloons, i.e to compare between the two groups the number of patients whose haemodialysis is efficient at 1 year without needing further treatment of the stenotic site after initial angioplasty.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
primary patency at 6 months
Description
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for primary patency at 6 months of the dilated stenosis
Time Frame
6 months
Title
overall primary patency of the Arteriovenous Fistula at 1 year
Description
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for overall primary patency of the Arteriovenous Fistula at 1 year (patency including AVF dysfunction in relation to the initial dilated stenosis as well as stenoses distant from the initially treated site)
Time Frame
1 year
Title
assisted primary patency of the dilated stenosis at 1 year
Description
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for assisted primary patency of the dilated stenosis at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions with new angioplasties on the initially dilated stenotic site (excluding de-obstruction for complete thrombosis)
Time Frame
1 year
Title
secondary patency of the AVF at 1 year
Description
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for secondary patency of the Arteriovenous Fistula at 1 year: Arteriovenous Fistula patency and continuation of efficient haemodialysis sessions also including complete thrombosis de-obstruction procedures
Time Frame
1 year
Title
The minimal diameter of the treated stenosis and the AVF flows
Description
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for the minimal diameter of the treated stenosis (Late Luminal Loss) and the Arteriovenous Fistula flows (both criterion being evaluated by Doppler ultrasound and Transonic® after angioplasty, and at 6 months and 1 year follow-up).
Time Frame
1 year
Title
Overall and cardiovascular survival
Description
during analysis in sub-groups, the advantage of these Drug-Eluting Balloons for Overall and cardiovascular survival at 2 and 5 years for all patients and for subgroup of patients with symptomatic peripheral artery disease
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18, Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days), Native and efficient arteriovenous fistula > 3 months, 3mm ≤ reference vein diameter ≤ 8 mm and stenosis length ≤ 10 cm (range of DEB diameters and lengths), Absence of fistula thrombosis, Possibility of crossing the stenosis with a guide wire, Significant stenosis > 50% (in relation to the reference diameter) on the fistulogram, Clinical diagnosis of imminent fistula dysfunction pressure rise during dialysis and/or puncture difficulties and/or recirculation or poor extrarenal clearance and/or decrease in vascular access flow and/or increase in compression time after dialysis Social security affiliation, Receipt of free, informed, written consent. Exclusion Criteria: Multiple stenoses, Goretex® graft prostheses Systemic or local infection, Known allergy to contrast agent or Paclitaxel. Comorbidity not permitting long-term follow-up, Life expectancy < 1 year, Anticancer treatment (patients treated with chemotherapy for neoplasia), Pregnant or breastfeeding woman, Patients over 18 years of age who are under legal protection (conservatorship, trusteeship, guardianship), or deprived of freedom.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Loïc JACOB
Phone
02 99 28 25 55
Email
drc@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Heautot, MD
Phone
02 99 28 43 21
Email
heautot@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François Heautot, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clément Marcelin
Email
clement.marcelin@chu-bordeaux.fr
Facility Name
Centre Hospitalier Universitaire de Caen
City
Caen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Le Pennec
First Name & Middle Initial & Last Name & Degree
Vincent Le Pennec
Facility Name
Centre Hospitalier Universitaire de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal Chabrot
First Name & Middle Initial & Last Name & Degree
Pascal Chabrot
Facility Name
Centre Hospitalier d'Haguenau
City
Haguenau
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Oswald
First Name & Middle Initial & Last Name & Degree
Pierre Oswald
Facility Name
APHM Hôpital la Timone
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Antoine Barral
First Name & Middle Initial & Last Name & Degree
Pierre-Antoine Barral
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Vernhet-Kovacsik
First Name & Middle Initial & Last Name & Degree
Hélène Vernhet-Kovacsik
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Sapoval
First Name & Middle Initial & Last Name & Degree
Marc Sapoval
Facility Name
Centre Hospitalier Universitaire de RENNES
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Heautot
First Name & Middle Initial & Last Name & Degree
Jean-François Heautot
First Name & Middle Initial & Last Name & Degree
Anthony Le Bras
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé Rousseau
First Name & Middle Initial & Last Name & Degree
Hervé Rousseau
First Name & Middle Initial & Last Name & Degree
Benoit Lebas
Facility Name
Clinique St Gatien de Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Turmel-Rodrigues
First Name & Middle Initial & Last Name & Degree
Luc Turmel-Rodrigues

12. IPD Sharing Statement

Learn more about this trial

Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty

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