Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty

NCT02913274 | Terminated DMC

• 1 other identifier: 2016-A00420-51
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 10

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.

Conditions

Stenosis of Arteriovenous Dialysis Fistula

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (6)

• primary patency at 6 months

  6 months

• overall primary patency of the Arteriovenous Fistula at 1 year

  1 year

• assisted primary patency of the dilated stenosis at 1 year

  1 year

• secondary patency of the AVF at 1 year

  1 year

• The minimal diameter of the treated stenosis and the AVF flows

  1 year

Study Arms (2)

"DEB" arm

EXPERIMENTAL

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.

Device: Paclitaxel (Taxol) eluting angioplasty balloon; Device: high-pressure angioplasty balloon

"conventional angioplasty" arm

ACTIVE COMPARATOR

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)

Device: high-pressure angioplasty balloon; Device: low-pressure balloon

Interventions

Paclitaxel (Taxol) eluting angioplasty balloon DEVICE

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.

Also known as: BARD, Lutonix® 035 and Lutonix®5F GeoAlign™

"DEB" arm

high-pressure angioplasty balloon DEVICE

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.

Also known as: BARD, Conquest®

"DEB" arm; "conventional angioplasty" arm

low-pressure balloon DEVICE

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.

Also known as: BARD, Ultraverse®

"conventional angioplasty" arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18,
• Stage 5 renal failure patients on permanent haemodialysis treatment (every 2 or 3 days),
• Native and efficient arteriovenous fistula \> 3 months,
• mm ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (10)

CHU Bordeaux

Bordeaux, France

Location

Centre Hospitalier Universitaire de Caen

Caen, France

Location

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, France

Location

Centre Hospitalier d'Haguenau

Haguenau, France

Location

APHM Hôpital la Timone

Marseille, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

Hôpital Européen Georges Pompidou

Paris, France

Location

Centre Hospitalier Universitaire de RENNES

Rennes, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Clinique St Gatien de Tours

Tours, France

Location

Study Officials

• Jean-François Heautot, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 23, 2016
• Study Start: March 20, 2017
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

FR (10)