F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm

NCT ID: NCT05247944

Last Updated: 2022-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2022-01-31

Brief Summary

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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

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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

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Aneurysm Aortic Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

Fenestrated and branched endovascular aortic repair (F-BEVAR)

Intervention Type 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).

Open repair

Intervention Type PROCEDURE

Open surgery for complex abdominal aortic aneurysm

Interventions

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Fenestrated and branched endovascular aortic repair (F-BEVAR)

Fenestrated and branched endovascular aortic repair (F-BEVAR)

Intervention Type PROCEDURE

Open repair

Open surgery for complex abdominal aortic aneurysm

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* juxtarenal abdominal aortic aneurysms
* pararenal abdominal aortic aneurysms
* suprarenal abdominal aortic aneurysms
* type IV thoracoabdominal aneurysms

Exclusion Criteria

* extent I to III thoracoabdominal aneurysms
* ruptured o symptomatic aneurysms
* dissections or connective tissue disorder aneurysms.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Chirurgical Marie Lannelongue

OTHER

Sponsor Role collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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TINELLI GIOVANNI

Head of the Endovascular Therapies Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
PMID: 29576405 (View on PubMed)

Other Identifiers

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1843

Identifier Type: -

Identifier Source: org_study_id

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