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

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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Abdominal Aortic Aneurysms

Detailed Description

Primary end-point is to evaluate the mortality and major adverse events (MAE) at 30 days, 2 years and 5 years prospectively in the cohort of patients p-AAA treated by means of open repair in the next 100 patients that will be treated between 2018 and 2020 in the Vascular Surgery Unit of the San Raffaele Hospital.

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.

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 The 100 patients that will be enrolled until December 2020 will also sign an "ad hoc" consents, specific for this study.

Sensitive patient information will not be available during data analysis. The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies.

Expected results are:

• death at 30 days: 2%
• any MAE at 30 day: 25% Patients characteristics and anatomical data on the visceral vessels will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

• Study Contact: Name: Alessandro Grandi, MD; Email: grandi.alessandro@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • IRCCS San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal aneurysm with hostile, para- / juxta-renal and supra-renal collars, undergoing open or surgical treatment.

Description

Inclusion Criteria:

• Patients age ≥18 years,
• Patient undergoing treatment of p-AAA pathology at San Raffaele Hospital

Exclusion Criteria:

• Incomplete imaging quality not including the arterial segments to be studied (visceral vessels) or with a high slice thickness (> 1.5 mm).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of participants mortality and major adverse events (MAE)	valuate the mortality and major adverse events (MAE) at 30 days, 2 years and 5 years prospectively in the cohort of patients p-AAA treated by means of open repair in the next 100 patients that will be treated between 2018 and 2020.	until 2025

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.
• Sugimoto M, Takahashi N, Niimi K, Kodama A, Banno H, Komori K. Long-term fate of renal function after open surgery for juxtarenal and pararenal aortic aneurysm. J Vasc Surg. 2018 Apr;67(4):1042-1050. doi: 10.1016/j.jvs.2017.07.121. Epub 2017 Sep 28.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: p-AAA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No