SuspendedNot Applicable

Aorto-iliac Occlusion Treatment With ShorT Unibody aorTic Endograft - ASTUTE Study

Stopped: Local ethics committee concern

Italy100 participantsStarted 2023-02-10

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patency rate

Timeframe: through study completion, an average of 30 days (short), 1-year (mid) and 5-years (long)".

Trial details

NCT IDNCT05614856

SponsorAzienda Ospedaliero-Universitaria di Modena

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03

View on ClinicalTrials.gov More Occlusive Arterial Disease trials