NCT03608683: p-AAA

Evaluation of the Treatment of Abdominal Aortic Pathology With Hostile Necks, Para-/Juxra-renal and Sovrarenal Pathology at Short, Mid and Long Term

Completed Last updated 24 January 2024

What this trial tests

trial in Proximal Abdominal Aortic Aneurysms in 100 participants. Completed in 31 December 2023.

Timeline

4 July 2018

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	IRCCS San Raffaele
Status	Completed
Study type	OBSERVATIONAL
Enrollment	100
Start date	4 July 2018
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Italy

Conditions studied

• Proximal Abdominal Aortic Aneurysms — all drugs for Proximal Abdominal Aortic Aneurysms →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

Adults 18 to 80, any sex, with Proximal Abdominal Aortic Aneurysms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Although open repair (OR) is currently reported as the gold standard of treatment, fenestrated endovascular repair (FEVAR) is being increasingly applied for the treatment of proximal abdominal aortic aneurysms (p-AAA) such as hostile-necked, juxta-, para- and supra-renal aortic aneurysms.1 Nevertheless, advantages of FEVAR in terms of lowering postoperative complications, should be balanced with the need of both complex device configurations and operators with large endovascular expertise. The aim of this study is to report the experience of Data from patients treated will be prospectively collected. All post-operative results will be recorded. Major adverse event (MAE) are defined as the presence of one of the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, respiratory failure, stroke and renal insufficiency.

Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed in our Unit for imaging assessment.

Patients will undergo standard control with the execution of a Doppler ultrasound and creatinine serum levels at 1, 6, 12, 24, 36, 48 and 60 months. A CTA will also be performed at 12 months as per standard clinical practice.

of p-AAA treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.