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Trial record 21 of 89 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty (FAVABED)

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ClinicalTrials.gov Identifier: NCT02913274
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment Phase
Stenosis of Arteriovenous Dialysis Fistula Device: Paclitaxel (Taxol) eluting angioplasty balloon Device: high-pressure angioplasty balloon Device: low-pressure balloon Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 262 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fistules Artério-Veineuses: Angioplastie Par Ballon à Elution de Drogue (FAVABED) - Arteriovenous Fistulae: Drug-eluting Balloon Angioplasty
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


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.
Device: Paclitaxel (Taxol) eluting angioplasty balloon
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 Name: BARD, Lutonix® 035 and Lutonix®5F GeoAlign™

Device: high-pressure angioplasty balloon
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 Name: BARD, Conquest®

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)
Device: high-pressure angioplasty balloon
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 Name: BARD, Conquest®

Device: low-pressure balloon
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 Name: BARD, Ultraverse®




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913274


Contacts
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Contact: Anne Hespel, PhD 02 99 28 25 55 drc@chu-rennes.fr
Contact: Jean-François Heautot, MD 02 99 28 43 21 heautot@chu-rennes.fr

Locations
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France
CHU Bordeaux Not yet recruiting
Bordeaux, France
Contact: Clément Marcelin         
Contact       clement.marcelin@chu-bordeaux.fr   
Centre Hospitalier Universitaire de Caen Not yet recruiting
Caen, France
Contact: Vincent Le Pennec         
Principal Investigator: Vincent Le Pennec         
Centre Hospitalier de Charleville Mézières Recruiting
Charleville Mézières, France
Contact: Philippe Cart         
Principal Investigator: Philippe Cart         
Centre Hospitalier Universitaire de Clermont-Ferrand Recruiting
Clermont-Ferrand, France
Contact: Pascal Chabrot         
Principal Investigator: Pascal Cahbrot         
Centre Hospitalier d'Haguenau Recruiting
Haguenau, France
Contact: Pierre Oswald         
Principal Investigator: Pierre Oswald         
APHM Hôpital la Timone Recruiting
Marseille, France
Contact: Vincent Vidal         
Principal Investigator: Vincent Vidal         
Centre Hospitalier Universitaire de Montpellier Recruiting
Montpellier, France
Contact: Hélène Vernhet-Kovacsik         
Principal Investigator: Hélène Vernhet-Kovacsik         
Hôpital Européen Georges Pompidou Recruiting
Paris, France
Contact: Marc Sapoval         
Principal Investigator: Marc Sapoval         
Centre Hospitalier Universitaire de RENNES Recruiting
Rennes, France
Contact: Jean-François Heautot         
Principal Investigator: Jean-François Heautot         
Sub-Investigator: Anthony Le Bras         
Centre Hospitalier Universitaire de Toulouse Recruiting
Toulouse, France
Contact: Hervé Rousseau         
Principal Investigator: Hervé Rousseau         
Clinique St Gatien de Tours Recruiting
Tours, France
Contact: Luc Turmel-Rodrigues         
Principal Investigator: Luc Turmel-Rodrigues         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jean-François Heautot, MD Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02913274     History of Changes
Other Study ID Numbers: 2016-A00420-51
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action