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Completed

NCT Number: NCT03477071

A 15-year Single Center Experience of Endovascular Treatment of Transplant Renal Artery Stenosis

Stenosis of the renal graft arteries occurs in 1 to 26% of cases and can damage the graft. Endovascular treatment is first-line treatment. The main objective of this study is to identify the predictive factors of failure of peri-anastomotic.

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Key information

Conditions

Unrecognized Condition

Sex eligibility

All sexes

Study type

Observational

About this study

The aim of this study was to evaluate the post-operative outcomes following endovascular treatment of TRAS (Transplant Renal Artery Stenosis).

This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017. The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients who had a renal transplant from brain-dead donors or from living donors
  • All patients who had a Transplant Renal Artery Stenosis

Exclusion criteria

  • None

Treatment and study plan

Angioplasty for Transplant Renal Artery Stenosis (TRAS)

Procedure

The angioplasty is an endovascular treatment for artery stenosis, which could be associated with stenting or not.

Other names: Endovascular treatment

Primary outcomes

  1. The technical success rate of endovascular treatment

    Time frame: 30 days

    The stenosis is defined by a reduction of at least 50% of the arterial diameter during arteriography. Technical success was defined as residual stenosis less than 30% of the arterial diameter after the procedure

Secondary outcomes

  1. Morbidity rate

    Time frame: 30 days

    Morbidity rate is defined as the development of post-operative complications. Minor and major complications are recorded, corresponding to Clavien Dindo classification

  2. Mortality rate

    Time frame: 30 days

    All death are recorded to identify the mortality rate

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Official study title

A 15-year Single Center Experience of Endovascular Treatment of Transplant Renal Artery Stenosis: Evaluation of Post-operative Outcomes

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 26, 2018
Registry last updated
Mar 26, 2018

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.

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