Endovascular Preparation for Kidney Tranplantation (EndoPreKiT)

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

Study Overview

• Status: Recruiting
• Conditions: Renal Failure Chronic; Kidney Transplant
• Intervention / Treatment: Other: This is an observational and retrospective study

• Study Type: Observational
• Enrollment (Estimated): 58

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Recruiting
    • HCL Hôpital Louis Pradel
    • Contact: Jean-Marc ALSAC
    • Contact: Fabien Thaveau
    • Contact: Mathieu ARSICOT; Phone Number: 0472117804; Email: mathieu.arsicot@chu-lyon.fr
    • Contact: Stephan HAULON
    • Contact: Xavier BERARD
    • Contact: Xavier CHAUFFOUR
    • Contact: Didier PLISSONIER
    • Contact: Eric STEINMETZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

single group of adult patients with chronic renal failure who are all awaiting a kidney transplant; This study focuses on a single group of 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	"From enrollment to the end of treatment at 12 months

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 1, 2024
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Actual): November 6, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 69HCL23_5431

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No