Endovascular Preparation for Kidney Tranplantation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorHospices Civils de Lyon
About this trial
This national study is a feasibility study. It wants to validate all stages of the endovascular preparation of the iliac axis up to the kidney transplant for patients in whom the installation of a tailor-made endoprosthesis was necessary beforehand.
These patients are currently at a therapeutic impasse. This strategy of renal transplantation on an iliac artery endoprosthesis could ultimately give them access to the transplant with an improvement in quality of life and survival, for lower costs of care for the hospital and safety. less social than treatment by hemodialysis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient from 18 to 85 years old (beyond 85 years old, guidance must remain exceptional)
Patients with chronic renal failure
Waiting for a kidney transplant
Who have a vascular contraindication to renal transplantation because of their anatomical constraints.
Disqualifiers
A progressive cancer, which is not cured,
An uncontrolled infectious disease,
Severe cardiovascular or respiratory disease making general anesthesia impossible,
Unstabilized psychiatric disorders or illness,
Trial population
This study concerns adult patients with chronic renal failure who are all awaiting a kidney transplant, whether or not they are treated by extra-renal purification. These patients are contraindicated for transplantation due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses and They can only receive the kidney transplant after arterial preparation.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
This is an observational and retrospective study
Other interventionIt concerns all patients with chronic renal failure awaiting a kidney transplant, and presenting a contraindication to the transplant due to their anatomical constraints: major arterial calcifications, iliac dissections, iliac stenoses. They can only receive the kidney transplant after arterial preparation. These patients will be included and will benefit from endovascular preparation for the kidney transplant using a tailor-made arterial stent. Imaging examinations and follow-up clinical data will be analyzed. Reinterventions and causes of death will be analyzed. An information sheet will be given to patients; if the patient refuses the use of their data, it will not be collected. Data collection will be carried out by ARCs or PIs of the centers from medical records. The data will be pseudo-anonymized, entered into a REDCAP database shared between each center.
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: single group of adult patients with chronic renal failure who are all awaiting a kidney transplant1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the success of endovascular arterial preparation for grafting Renal.
The success of arterial preparation for renal transplantation will be evaluated by: * Collect safety estimators, absence of serious complications (hemorrhage, acute/subacute ischemia of the lower limb, death, serious post-operative cardiorespiratory event, failure of renal function for non-dialysis patients) Validity at 1 month of an endovascular preparation for renal transplantation by tailor-made arterial stent by the success of the installation, the absence of endoleak and the good anteroposterior positioning of the stent * Effectiveness at 1 month of endovascular preparation for renal transplantation by tailor-made arterial stent by permeability confirmed by Doppler ultrasound
Time frame
"From enrollment to the end of treatment at 12 monthsSponsors and contacts
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Source ClinicalTrials.gov