Vascular Diseases Clinical Trial
Official title:
Propensity Matched Comparison of Fenestrated Endovascular Aneurysm Repair and Open Surgical Repair for Complex Abdominal Aortic Aneurysms.
NCT number | NCT05247944 |
Other study ID # | 1843 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2010 |
Est. completion date | January 2022 |
Verified date | February 2022 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 278 |
Est. completion date | January 2022 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Centre Chirurgical Marie Lannelongue |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall mortality | All cause death | Through study completion, an average of 5 year | |
Primary | Aortic-related mortality | Any death related to the initial procedure. | Through study completion, an average of 5 year | |
Primary | 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. | Through study completion, an average of 5 year | |
Secondary | Aortic-related reintervention | All secondary interventions related to the initial procedure or to the endograft and its target vessels during follow-up | Through study completion, an average of 5 year | |
Secondary | Target vessel occlusion | Complete obstruction of the artery with no evidence of flow identified on any follow-up CT scan or duplex ultrasound. | Through study completion, an average of 5 year | |
Secondary | 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. | Through study completion, an average of 5 year | |
Secondary | 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 | Through study completion, an average of 5 year |
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