Outcomes After Visceral Aortic Coral Reef Surgery

• Sponsor: University Paul Sabatier of Toulouse (Other)
• Overall Status: Completed
• CT.gov ID: NCT05983510
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Actual Duration (Months): 65.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Coral Reef	Procedure: Aortic endarteriectomy

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 Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Long Term Outcomes After Visceral Aortic Endarteriectomy for Coral Reef Lesion
• Actual Study Start Date: Jan 1, 2018
• Actual Primary Completion Date: Jan 1, 2023
• Actual Study Completion Date: Jul 1, 2023

Outcome Measures

Primary Outcome Measures

1. Major adverse cardiac event (MACE) [1 month after surgery]

   Post operative cardiologic complication

2. Reintervention [1 month after surgery]

   Need of reintervention before discharge

Secondary Outcome Measures

1. Long term follow up [1 month, 1 year, yearly up to 5 years]

   Cumulative survival rate

2. Target vessel patency [1 month, 1 year, yearly up to 5 years]

   Permeability of the different vessel (renal and visceral arteries) on CT scan or Duplex ultrasound

3. Kidney function evolution [1 month, 1 year, yearly up to 5 years]

   glomerular filtration rate evolution,

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hostalrich Aurélien	Toulouse		France	31059

Sponsors and Collaborators

• University Paul Sabatier of Toulouse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aurélien Hostalrich, MD,PhD Principal investigator, University Paul Sabatier of Toulouse
• ClinicalTrials.gov Identifier: NCT05983510
• Other Study ID Numbers: Long term Coral Reef
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 9, 2023