Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty

Status: Terminated
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Bordeaux
Bordeaux
Centre Hospitalier Universitaire de Caen
Caen
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-ferrand
Centre Hospitalier d'Haguenau
Haguenau
APHM Hôpital la Timone
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier
Hôpital Européen Georges Pompidou
Paris
Centre Hospitalier Universitaire de RENNES
Rennes
Centre Hospitalier Universitaire de Toulouse
Toulouse
Clinique St Gatien de Tours
Tours
Time Frame
Start Date: 2017-03-20
Completion Date: 2020-04-21
Participants
Target number of participants: 115
Treatments
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.
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)
Related Therapeutic Areas
Sponsors
Leads: Rennes University Hospital

This content was sourced from clinicaltrials.gov