NCT03477071

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

7 years

First QC Date

March 20, 2018

Last Update Submit

March 20, 2018

Conditions

Keywords

Transplant renal artery stenosisEndovascular repairPost-operative outcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Morbidity rate

    30 days

  • Mortality rate

    30 days

Interventions

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

Also known as: Endovascular treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 26, 2018

Study Start

January 1, 2010

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Submission at several congress: WCE2017, AFU2017 Publication at the Journal of Urology in March 2018