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Clinical Trials in France / NCT06677437
Recruiting Observational

Endovascular Preparation for Kidney Tranplantation

NCT06677437 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-01-01
Last updated
2024-11-06

Condition(s) studied

Renal Failure ChronicKidney Transplant

Investigational drug(s) / intervention(s)

This is an observational and retrospective study

This 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.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
HCL Hopital Louis Pradel Bron France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06677437 on ClinicalTrials.gov ↗ ← All trials in France