- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02913274
Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty (FAVABED)
Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Loïc JACOB
- Phone Number: 02 99 28 25 55
- Email: drc@chu-rennes.fr
Study Contact Backup
- Name: Jean-François Heautot, MD
- Phone Number: 02 99 28 43 21
- Email: heautot@chu-rennes.fr
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
-
Caen, France
- Centre Hospitalier Universitaire de Caen
-
Clermont-Ferrand, France
- Centre Hospitalier Universitaire de Clermont-Ferrand
-
Haguenau, France
- Centre Hospitalier d'Haguenau
-
Marseille, France
- APHM Hôpital la Timone
-
Montpellier, France
- Centre Hospitalier Universitaire de Montpellier
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Paris, France
- Hopital Europeen Georges Pompidou
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Rennes, France
- Centre Hospitalier Universitaire De Rennes
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Toulouse, France
- Centre Hospitalier Universitaire de Toulouse
-
Tours, France
- Clinique St Gatien de Tours
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: "DEB" arm
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.
|
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.
Other Names:
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.
Other Names:
|
Active Comparator: "conventional angioplasty" arm
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)
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary patency at 6 months
Time Frame: 6 months
|
assess the advantages of Drug-Eluting Balloon compared to conventional plain balloon for primary patency at 6 months of the dilated stenosis
|
6 months
|
overall primary patency of the Arteriovenous Fistula at 1 year
Time Frame: 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)
|
1 year
|
assisted primary patency of the dilated stenosis at 1 year
Time Frame: 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)
|
1 year
|
secondary patency of the AVF at 1 year
Time Frame: 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
|
1 year
|
The minimal diameter of the treated stenosis and the AVF flows
Time Frame: 1 year
|
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).
|
1 year
|
Overall and cardiovascular survival
Time Frame: 5 years
|
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
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-François Heautot, MD, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Arteriovenous Fistula
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- 2016-A00420-51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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