NCT05983510

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

5 years

First QC Date

July 19, 2023

Last Update Submit

August 6, 2023

Conditions

Aortic Coral Reef

Outcome Measures

Primary Outcomes (2)

  • Major adverse cardiac event (MACE)

    Post operative cardiologic complication

    1 month after surgery

  • Reintervention

    Need of reintervention before discharge

    1 month after surgery

Secondary Outcomes (3)

  • Long term follow up

    1 month, 1 year, yearly up to 5 years

  • Target vessel patency

    1 month, 1 year, yearly up to 5 years

  • Kidney function evolution

    1 month, 1 year, yearly up to 5 years

Interventions

Aortic endarteriectomyPROCEDURE

Thoraco-phreno-lumbotomy with thoracic aortic cross clamping Longitudinal aortotomy Endarteriectomy of the aorta Direct closure more or less bypass to the visceral arteries and downstream aorta reconstruction.

Eligibility Criteria

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

All patients who needed a coral reef surgery were included

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hostalrich Aurélien

Toulouse, 31059, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD Principal investigator

Study Record Dates

First Submitted

July 19, 2023

First Posted

August 9, 2023

Study Start

January 1, 2018

Primary Completion

January 1, 2023

Study Completion

July 1, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

FR(1)