Endovascular Preparation for Kidney Tranplantation

NCT06677437 | Recruiting

• 1 other identifier: 69HCL23_5431
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Failure Chronic; Kidney Transplant

Outcome Measures

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

  "From enrollment to the end of treatment at 12 months

Study Arms (1)

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

Interventions

This is an observational and retrospective study OTHER

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.

single group of adult patients with chronic renal failure who are all awaiting a kidney transplant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

HCL Hopital Louis Pradel

Bron, 69500, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Case-Control Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Cohort Studies; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: November 6, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)