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

Unrecognized Condition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477071
• Other study ID #: URO-BASE03
• Status: Completed
• First received: March 20, 2018
• Last updated: March 20, 2018
• Start date: January 1, 2010
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1323
• Est. completion date: December 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Constriction, Pathologic
• Renal Artery Obstruction
• Unrecognized Condition

Intervention

Procedure:
• Angioplasty for Transplant Renal Artery Stenosis (TRAS)
The angioplasty is an endovascular treatment for artery stenosis, which could be associated with stenting or not.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice	Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Mortality rate	All death are recorded to identify the mortality rate	30 days