Endovascular Preparation for Kidney Tranplantation

NCT ID: NCT06677437

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-01-01

Brief Summary

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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

Detailed Description

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Conditions

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Renal Failure Chronic Kidney Transplant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

This is an observational and retrospective study

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HCL Hopital Louis Pradel

Bron, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Mathieu ARSICOT

Role: primary

0472117804

Stephan HAULON

Role: backup

Xavier BERARD

Role: backup

Xavier CHAUFFOUR

Role: backup

Didier PLISSONIER

Role: backup

Fabien THAVEAU

Role: backup

Eric STEINMETZ

Role: backup

Jean-Marc ALSAC

Role: backup

Other Identifiers

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69HCL23_5431

Identifier Type: -

Identifier Source: org_study_id

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