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

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

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.

Study Overview

• Status: Completed
• Conditions: Unrecognized Condition
• Intervention / Treatment: Procedure: Angioplasty for Transplant Renal Artery Stenosis (TRAS)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1323

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

This retrospective, monocentric study included patients with peri-anastomotic stenosis of the renal graft from 2000 to 2017.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The technical success rate of endovascular treatment	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	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity rate	Morbidity rate is defined as the development of post-operative complications. Minor and major complications are recorded, corresponding to Clavien Dindo classification	30 days
Mortality rate	All death are recorded to identify the mortality rate	30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 26, 2018
• Last Update Submitted That Met QC Criteria: March 20, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Transplant renal artery stenosis; Endovascular repair; Post-operative outcome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Constriction, Pathologic; Renal Artery Obstruction
• Other Study ID Numbers: URO-BASE03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Submission at several congress: WCE2017, AFU2017 Publication at the Journal of Urology in March 2018

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