Aortic Coral ReefNCT05983510
Outcomes After Visceral Aortic Coral Reef Surgery
An observational study of Aortic Coral Reef, run by University Paul Sabatier of Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Coral Reef
- What is being tested?
- Aortic endarteriectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who needed a coral reef surgery were included
Who may be able to join
- Coral reef surgery
- Urgent intervention
- Claudication, renal, visceral involvement
- Thoracic aortic cross clamping (above coeliac trunk)
Who cannot join
- "simple" visceral aorto thrombectomy without opening laterally the aorta
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Coral Reef
- Being tested
- Aortic endarteriectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic endarteriectomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac event (MACE)
Post operative cardiologic complication
Measured: 1 month after surgery
Reintervention
Need of reintervention before discharge
Measured: 1 month after surgery
Secondary outcomes (3)
Long term follow up
Cumulative survival rate
Measured: 1 month, 1 year, yearly up to 5 years
Target vessel patency
Permeability of the different vessel (renal and visceral arteries) on CT scan or Duplex ultrasound
Measured: 1 month, 1 year, yearly up to 5 years
Kidney function evolution
glomerular filtration rate evolution,
Measured: 1 month, 1 year, yearly up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jan 2018
- Primary completion1 Jan 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Coral ReefStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aurélien Hostalrich, University Paul Sabatier of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983510
- Sponsor's protocol ID
- Long term Coral Reef
- Status last verified
- Aug 2023
- First submitted
- 19 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcomes After Visceral Aortic Endarteriectomy for Coral Reef Lesion
- ClinicalTrials.gov ID
- NCT05983510
- Acronym / sponsor ID
- Long term Coral Reef
- Conditions
- Aortic Coral Reef
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who needed a coral reef surgery were included
Key inclusion criteria (4 listed)
- Coral reef surgery
- Urgent intervention
- Claudication, renal, visceral involvement
- Thoracic aortic cross clamping (above coeliac trunk)
Key exclusion criteria (2 listed)
- "simple" visceral aorto thrombectomy without opening laterally the aorta
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aortic endarteriectomyThoraco-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. | Procedure or surgery | – |
Primary outcome
Major adverse cardiac event (MACE)
Time frame: 1 month after surgery
Post operative cardiologic complication
Reintervention
Time frame: 1 month after surgery
Need of reintervention before discharge
3 secondary outcomes
Long term follow up
Time frame: 1 month, 1 year, yearly up to 5 years
Target vessel patency
Time frame: 1 month, 1 year, yearly up to 5 years
Kidney function evolution
Time frame: 1 month, 1 year, yearly up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Coral Reef, run by University Paul Sabatier of Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac event (MACE) (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.