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

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

The goal of this multicenter, observational cohort study is to evaluates the clinical effectiveness of a single-renal scallop custom-made stent-graft (TREO, Terumo Aortic, Sunrise, FL) to treat hostile AAA with mismatched renal arteries as actual standard of care in this Vascular Unit The main question it aims to answer are: if a dedicated devices could improve the results in the endovascular treatment of patients suffering to infrarenal abdominal aortic aneurism with a mismatched takeoff of the renal arteries. Participants responding to inclusion criteria will be treated as best clinical practice with a custom made device with a single scallop for the renal artery. The minimum follow-up requested, as standard clinical practice, was: 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. No comparison group was present.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Italy
AOU di Modena
Baggiovara
Time Frame
Start Date: 2023-02-01
Completion Date: 2025-09-28
Participants
Target number of participants: 50
Treatments
AAA patients with a mismatched takeoff of the renal arteries candidated to standard EVAR
Patients suffering to AAA with a mismatched takeoff (\>10mm) of the renal arteries
Sponsors
Collaborators: Azienda Ospedaliera Ordine Mauriziano di Torino, Azienda Ospedaliera di Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Ospedale di Circolo - Fondazione Macchi, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Leads: Azienda Ospedaliero-Universitaria di Modena

This content was sourced from clinicaltrials.gov