Trials / Completed
CompletedNCT05247944
F-BEVAR vs Open Surgery for Complex Abdominal Aortic Aneurysm
Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 278 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Fenestrated and branched endovascular aortic repair (F-BEVAR) | Fenestrated and branched endovascular aortic repair (F-BEVAR) |
| PROCEDURE | Open repair | Open surgery for complex abdominal aortic aneurysm |
Timeline
- Start date
- 2010-01-01
- Primary completion
- 2018-01-31
- Completion
- 2022-01-01
- First posted
- 2022-02-21
- Last updated
- 2022-02-21
Source: ClinicalTrials.gov record NCT05247944. Inclusion in this directory is not an endorsement.