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NCT05609539
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm
Conditions: Abdominal Aortic Aneurysm
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: Azienda Ospedaliero-Universitaria di Modena
Location: Italy
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 Criteria
Inclusion Criteria:Patients affected by infrarenal AAA > 50mmTreated in election for non-symptomatic AAAAnatomy inside Treo (Terumo Aortic) instruction to use (IFU)Distance between renal arteries >10mm on aortic center-lumen-lineAge > 18Patient fit to pleadBoth sexWritten informed consentTreated in the coordinator center or in one of the study's participating centersMinimum 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 thereafterExclusion Criteria:Patients with aortic pathologies different from AAA (aortic ulcers, dissection, pseudo-aneurysm etc)Treated in urgent/emergent setting for symptomatic or ruptured AAAAAA < 50mmOutside TREO (Terumo Aortic) IFUWith an inter-renal distance measured of the center-lumen-line <10mmAge <18Unfit to pleadRefused to sign the informed consentTreated outside the coordinator centers or in one of the study's participating center'sRefusal to adhere to the requested follow-up
Source: ClinicalTrials.gov (NCT05609539). StuddyBuddy aggregates publicly available trial information.