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Endovascular Preparation for Kidney Tranplantation

Endovascular Preparation for Kidney Tranplantation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06677437
Acronym
EndoPreKiT
Enrollment
58
Registered
2024-11-06
Start date
2024-01-01
Completion date
2028-01-01
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant, Renal Failure Chronic

Brief summary

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

Interventions

OTHERThis is an observational and retrospective study

It 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. Patient from 18 to 85 years old (beyond 85 years old, guidance must remain exceptional) 2. Patients with chronic renal failure 3. Waiting for a kidney transplant 4. Who have a vascular contraindication to renal transplantation because of their anatomical constraints.

Exclusion criteria

1-All criteria contraindicating kidney transplant other than for arterial anatomical problems: All criteria contraindicating kidney transplant other than for arterial anatomical problems: * 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, * Dementia proven to have progressed after specialist advice * Major obesity, with a body mass index greater than 50 kg/m2 * Patient refusal 2. Patient under curatorship 3. Pregnant woman 4. Patients for whom it will not be possible to organize regular medical follow-up

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the success of endovascular arterial preparation for grafting Renal.From enrollment to the end of treatment at 12 monthsThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026