Monocenter Feasibility Study using the fenestrated ANACONDA endograft for juxta- and suprarenal abdominal aorta aneurysm repair

Completed

• Conditions: aorta aneursym; 10003184; 10002363

• Registration Number: NL-OMON36025
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• Patients aged 18 years - 90 Years
* Patient willing and available to comply with follow up requirements
* Patient can comply with instructions and give informed consent
* Life Expectancy > 2 Years
* AAA > 55 mm in diameter
* Suprarenal proximal neck diameter 18 - 31.5mm
* Inadequate infrarenal aortic neck sealing zone
* Distal Iliac fixation site diameter < =17 mm
* Distal Iliac fixation site >= 20 mm in length.
* Access vessels: Appropriate anatomy, at the physicians discretion, for access vessel suitability
* Aortic neck angulation <= 90 degrees.

Exclusion Criteria

Ruptured AAA
* Presence of serious concomitant medical disease or infection
* Low operative risk for open repair
* Known allergy to contrast medium, nitinol or polyester
* Connective tissue disease
* ASA Grade IV or V
* Need for surgical reconstruction of other visceral arteries or inability to place stent in visceralartery
* Presence of > 50% continuous calcification of proximal neck
* Presence of > 50% thrombus in proximal neck
* Other unsuitable anatomy

Study & Design

• Study Type: Interventional
• Study Design: Not specified