Aneurysm AorticNCT05247944
F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm
An observational study of Aneurysm Aortic and Vascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aneurysm Aortic, Vascular Diseases
- What is being tested?
- Fenestrated and branched endovascular aortic repair (F-BEVAR) and Open repair
- Type of treatment
- Surgery or procedure
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2022
- 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: A total of 157 patients, referred to the Aortic Center of Lille (France), underwent F-BEVAR treatment; 119 patients, referred to the Policlinic Gemelli in Rome (Italy), concurrently underwent OSR.
Who may be able to join
- juxtarenal abdominal aortic aneurysms
- pararenal abdominal aortic aneurysms
- suprarenal abdominal aortic aneurysms
- type IV thoracoabdominal aneurysms
Who cannot join
- extent I to III thoracoabdominal aneurysms
- ruptured o symptomatic aneurysms
- dissections or connective tissue disorder aneurysms.
About this study
Official title: Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.
Read the detailed description
This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).
Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.
- Conditions
- Aneurysm Aortic, Vascular Diseases
- Being tested
- Fenestrated and branched endovascular aortic repair (F-BEVAR), Open repair
- Keywords
- F-BEVAR, Open surgery, complex abdominal aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fenestrated and branched endovascular aortic repair (F-BEVAR)Procedure or surgery
Fenestrated and branched endovascular aortic repair (F-BEVAR)
Open repairProcedure or surgery
Open surgery for complex abdominal aortic aneurysm
| Study group | Role | What they receive |
|---|---|---|
| F-BEVAR | Patients with complex abdominal aortic aneurysm who underwent fenestrated and branched endovascular aortic repair (F-BEVAR) at the Aortic Center of Lille (ACL; Lille, France). Receives: Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR) | |
| OPEN SURGERY REPAIR | Patients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy). Receives: Procedure: Open repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall mortality
All cause death
Measured: Through study completion, an average of 5 year
Aortic-related mortality
Any death related to the initial procedure.
Measured: Through study completion, an average of 5 year
Chronic renal decline during follow-up
Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to <60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of >20% or de novo dependence on permanent renal replacement therapy.
Measured: Through study completion, an average of 5 year
Secondary outcomes (4)
Aortic-related reintervention
All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up
Measured: Through study completion, an average of 5 year
Target vessel occlusion
Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound.
Measured: Through study completion, an average of 5 year
Clinical failure
Death from complications of the initial operation or a secondary intervention, aortic aneurysm rupture, aortic conversion to open surgical repair, persistent type I or III endoleak, sac expansion >5 mm, device migration >10mm, infection or thrombosis in the F-BEVAR group and death, graft infection or thrombosis or para-anastomotic aneurysm in the open group.
Measured: Through study completion, an average of 5 year
Proximal aorta degeneration Proximal aorta degeneration
Diameter increase >5 mm within 5 cm above the ostium of the more proximal target vessel for the endovascular group and 5 cm above the proximal anastomosis for the open group
Measured: Through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study startJan 2010
- Primary completion31 Jan 2018
- Study completionJan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysm AorticStudies 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
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Chirurgical Marie Lannelongue
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05247944
- Sponsor's protocol ID
- 1843
- Status last verified
- Feb 2022
- First submitted
- 31 Jan 2022
- Last updated
- 21 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinelli G, Crea MA, de Waure C, Di Tanna GL, Becquemin JP, Sobocinski J, Snider F, Haulon S. A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms. J Vasc Surg. 2018 Sep;68(3):659-668. doi: 10.1016/j.jvs.2017.12.060. Epub 2018 Mar 22.
PubMed 29576405
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
- ClinicalTrials.gov ID
- NCT05247944
- Acronym / sponsor ID
- 1843
- Conditions
- Aneurysm Aortic, Vascular Diseases
- Keywords
- F-BEVAR, Open surgery, complex abdominal aortic aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Centre Chirurgical Marie Lannelongue
- Study start
- Jan 2010
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 21 Feb 2022 (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.
The aim of the present study was to investigate outcomes of a propensity matched series of patients treated with F-BEVAR and open surgery repair for complex abdominal aortic aneurysm in two aortic high-volume centres.
Detailed description
This retrospective study analyzes the long-term outcomes of a propensity-matched cohort of patients with complex abdominal aortic aneurysm prospectively collected between January 2010 and June 2016 from the Aortic Center of Lille (Lille, France) and the Unit of Vascular Surgery of Policlinic Gemelli (Rome, Italy).
Patients were observed with regular postoperative appointments. The long-term imaging follow-up consisted in a yearly computed tomography angiography in the F-BEVAR group; and yearly abdominal ultrasound examination and 5-year computed tomography angiography were performed in the open surgery repair group. In case of abnormal renal function (eGFR<60 mL/min/1.73 m2), the patient underwent computed tomography without contrast associated to a contrast-enhanced ultrasound examination in both groups. Laboratory data with evaluation of renal function by estimated glomerular filtration rate (eGFR), were completed at three, six, and 12 months, and yearly thereafter. Survival assessment was completed after general partitioner's, patients' or patient siblings' contact by phone.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-BEVAR | – | Procedure: Fenestrated and branched endovascular aortic repair (F-BEVAR)Patients with complex abdominal aortic aneurysm who underwent fenestrated and branched endovascular aortic repair (F-BEVAR) at the Aortic Center of Lille (ACL; Lille, France). |
| OPEN SURGERY REPAIR | – | Procedure: Open repairPatients with complex abdominal aortic aneurysm who underwent open surgery repair the Unit of Vascular Surgery of Policlinic Gemelli (FPUG; Rome, Italy). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 157 patients, referred to the Aortic Center of Lille (France), underwent F-BEVAR treatment; 119 patients, referred to the Policlinic Gemelli in Rome (Italy), concurrently underwent OSR.
Key inclusion criteria (4 listed)
- juxtarenal abdominal aortic aneurysms
- pararenal abdominal aortic aneurysms
- suprarenal abdominal aortic aneurysms
- type IV thoracoabdominal aneurysms
Key exclusion criteria (3 listed)
- extent I to III thoracoabdominal aneurysms
- ruptured o symptomatic aneurysms
- dissections or connective tissue disorder aneurysms.
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 |
|---|---|---|
| Fenestrated and branched endovascular aortic repair (F-BEVAR)Fenestrated and branched endovascular aortic repair (F-BEVAR) | Procedure or surgery | F-BEVAR |
| Open repairOpen surgery for complex abdominal aortic aneurysm | Procedure or surgery | OPEN SURGERY REPAIR |
Primary outcome
Overall mortality
Time frame: Through study completion, an average of 5 year
All cause death
Aortic-related mortality
Time frame: Through study completion, an average of 5 year
Any death related to the initial procedure.
Chronic renal decline during follow-up
Time frame: Through study completion, an average of 5 year
Chronic renal decline was defined in patients with normal (stage 1-2) preoperative renal function as a reduction in the eGFR to <60 mL/min/1.73 m2 during follow-up. In patients with abnormal function (stages 3 and 4) preoperatively, it was defined as an eGFR reduction of >20% or de novo dependence on permanent renal replacement therapy.
4 secondary outcomes
Aortic-related reintervention
Time frame: Through study completion, an average of 5 year
Target vessel occlusion
Time frame: Through study completion, an average of 5 year
Clinical failure
Time frame: Through study completion, an average of 5 year
Proximal aorta degeneration Proximal aorta degeneration
Time frame: Through study completion, an average of 5 year
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 21 Feb 2022.
- Background: PubMed 29576405Tinelli G, Crea MA, de Waure C, Di Tanna GL, Becquemin JP, Sobocinski J, Snider F, Haulon S. A propensity-matched comparison of fenestrated endovascular aneurysm repair and open surgical repair of pararenal and paravisceral aortic aneurysms. J Vasc Surg. 2018 Sep;68(3):659-668. doi: 10.1016/j.jvs.2017.12.060. Epub 2018 Mar 22.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Aortic and Vascular Diseases, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 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 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Overall mortality (time frame: Through study completion, an average of 5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05247944, which also lists 1 linked publication.
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 21 Feb 2022.