Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck In… (NCT05609539) | Clinical Trial Compass
CompletedNot Applicable
Clinical Effectiveness of an Off-the-shelf Single REnal Scalloped sTent-graft for HOstile NEck Infrarenal Abdominal Aortic Aneurysm
Italy50 participantsStarted 2023-02-01
Plain-language 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.
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:
* 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
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
1
Evaluation of the clinical effectiveness of the endovascular exclusion of infrarenal Abdominal Aortic Aneurysm with a single renal scallop endograft
Timeframe: up to 24 hours
Trial details
NCT IDNCT05609539
SponsorAzienda Ospedaliero-Universitaria di Modena