Outcomes After Visceral Aortic Coral Reef Surgery

August 6, 2023 updated by: Aurélien Hostalrich, University Paul Sabatier of Toulouse

Long Term Outcomes After Visceral Aortic Endarteriectomy for Coral Reef Lesion

Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy. Little is know about the outcomes after such aggressive surgery with short series and short follow up.

The authors propose a retrospective study from their institution to explore the post operative and long term outcomes after this surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Coral reef aorta is defined by a calcified stenosis of the visceral aorta which can cause leg claudication, renal failure and visceral ischemia depending the type and localisation of the stenosis.

This pathology is rare and is usually treated by open surgery with aortic endarteriectomy.

Little is known in the literature regarding the outcomes of this aggressive surgery.

The authors propose a retrospective study from their institution describing the type of surgery realised. They describe the post operative outcomes of this surgery in term of cardiologic, respiratory, renal complication a,d surgical complication.

Moreover they follow the patients to present long term outcomes of this pathology with a description of the post operative recurrence of a coral reef, the permeability of the different target vessel and the cardiologic, respiratory and renal evolution of the different patients.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Toulouse, France, 31059
        • Hostalrich Aurélien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who needed a coral reef surgery were included

Description

Inclusion Criteria:

  • Coral reef surgery
  • Urgent intervention
  • Claudication, renal, visceral involvement
  • Thoracic aortic cross clamping (above coeliac trunk)

Exclusion Criteria:

  • "simple" visceral aorto thrombectomy without opening laterally the aorta
  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac event (MACE)
Time Frame: 1 month after surgery
Post operative cardiologic complication
1 month after surgery
Reintervention
Time Frame: 1 month after surgery
Need of reintervention before discharge
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long term follow up
Time Frame: 1 month, 1 year, yearly up to 5 years
Cumulative survival rate
1 month, 1 year, yearly up to 5 years
Target vessel patency
Time Frame: 1 month, 1 year, yearly up to 5 years
Permeability of the different vessel (renal and visceral arteries) on CT scan or Duplex ultrasound
1 month, 1 year, yearly up to 5 years
Kidney function evolution
Time Frame: 1 month, 1 year, yearly up to 5 years
glomerular filtration rate evolution,
1 month, 1 year, yearly up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

July 19, 2023

First Submitted That Met QC Criteria

August 6, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Long term Coral Reef

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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