Recruiting

NCT Number: NCT06677437

Endovascular Preparation for Kidney Tranplantation

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

HCL Hopital Louis Pradel

Bron, 69500, France

Location status: Recruiting

Location contact

Didier PLISSONIER

CONTACT

Eric STEINMETZ

CONTACT

Fabien THAVEAU

CONTACT

Jean-Marc ALSAC

CONTACT

Mathieu ARSICOT

CONTACT

[email protected]

0472117804

Stephan HAULON

CONTACT

Xavier BERARD

CONTACT

Xavier CHAUFFOUR

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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

Treatment and study plan

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.

Primary outcomes

Evaluate the success of endovascular arterial preparation for grafting Renal.

Time frame: "From enrollment to the end of treatment at 12 months
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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EndoPreKiT

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2028
First posted: Nov 6, 2024
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting