Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02913274 |
| Other study ID # |
2016-A00420-51 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2017 |
| Est. completion date |
April 21, 2020 |
Study information
| Verified date |
December 2023 |
| Source |
Rennes University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
