Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA · Nov 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with a type of condition called abdominal aortic aneurysm (AAA), specifically when the blood vessels leading to the kidneys are not in the usual position. The trial is testing a special stent-graft, which is a tube used to support the blood vessel and prevent it from leaking or bursting. The main aim is to see if this customized device can improve the outcomes for patients who have this challenging situation with their renal arteries.

To participate in this study, individuals must be at least 18 years old and diagnosed with an AAA larger than 50mm. They should be scheduled for a planned, non-emergency treatment and have specific measurements between their renal arteries. Participants will undergo the treatment and will have follow-up appointments to monitor their health at various intervals over five years. It’s important to note that this study does not have a comparison group, meaning that all participants will receive the same treatment. Overall, this trial aims to find out if this new stent-graft can provide better care for patients with complex AAA cases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients affected by infrarenal AAA \> 50mm
• • Treated in election for non-symptomatic AAA
• • Anatomy inside Treo (Terumo Aortic) instruction to use (IFU)
• • Distance between renal arteries \>10mm on aortic center-lumen-line
• • Age \> 18
• • Patient fit to plead
• • Both sex
• • Written informed consent
• • Treated in the coordinator center or in one of the study's participating centers
• • Minimum follow-up requested: 3-months, 12-18 months and 5-years CTA; clinical and DUS examination at 6- and 12- and 36-months after the intervention and yearly thereafter
• Exclusion Criteria:
• • Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc)
• • Treated in urgent/emergent setting for symptomatic or ruptured AAA
• • AAA \< 50mm
• • Outside TREO (Terumo Aortic) IFU
• • With an inter-renal distance measured of the center-lumen-line \<10mm
• • Age \<18
• • Unfit to plead
• • Refused to sign the informed consent
• • Treated outside the coordinator centers or in one of the study's participating center's
• • Refusal to adhere to the requested follow-up