- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05983510
Outcomes After Visceral Aortic Coral Reef Surgery
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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France, 31059
- Hostalrich Aurélien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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