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Recruiting
NCT05614856
Aorto-iliac Occlusion Treatment With ShorT Unibody aorTic Endograft - ASTUTE Study
Conditions: Occlusive Arterial Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Azienda Ospedaliero-Universitaria di Modena
Location: Italy
Summary
The goal of this multi center prospective observational study is to evaluate the iliac patency rate during the time in patients treated with "AFX (Endologix, Irvine Calif)" unibody stent-graft for aorto-iliac occlusive disease The main question it aims to answer is if The Unibody AFX (Endologix) endograft could be in a large and real-world cohort of patients effective solution for the less-invasive treatment of the aortoiliac occlusive disease (AIOD).Participants affected by AIOD with an indication of endovascular treatment will be prospectively enrolled and treated as our clinical practice.
The requested follow-up did not differ from the one suggested by the most recent guidelines
Eligibility Criteria
Inclusion Criteria:Age >18;Both sex;Preoperative 2.5mm CTA available;Written informed consent;Patients affected by AIOD classified as TASC B (with aortic involvement) C or D involving aortic bifurcation and or the first 5mm of one of both common iliacs;Treated in the coordinator center or in one of the study's participating center's;With a calcium volume in target zone based on real lumen of less than 20% and absence of circumferential calcifications;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:Age<18;No preoperative 2.5mm CTA available;Refused to sign the informed consent;Treated outside the coordinator centers or in one of the study's participating centers;Refusal to adhere to the requested follow-up;Patients affected by AIOD classified as TASC A or not involving aortic bifurcation or the first 5mm of one of both common iliacs;With a calcium volume in target zone based on real lumen of more than 20% and presence of circumferential calcifications;
Source: ClinicalTrials.gov (NCT05614856). StuddyBuddy aggregates publicly available trial information.