Cost-helpful look at iliac branch endoprostheses in aorto-iliac aneurysm repairs
Official title: Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model
Run by IRCCS San Raffaele · NCT07096388 · Data updated 2026-11-12
This observational study tests the cost-effectiveness of Iliac Branch Endoprostheses in adults who undergo open or endovascular repair for aorto-iliac aneurysm.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | IRCCS San Raffaele Academic / other |
| Locations | 1 site (Miano, Italy) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | December 1, 2029 |
| Study ends | March 1, 2030 |
| Registry record updated | September 17, 2026 |
| Trial ID | NCT07096388 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with an aorto-iliac aneurysm who are treated with elective open repair or iliac branch endovascular repair at IRCCS San Raffaele Hospital.
✕Probably not a fit
Patients treated with hybrid approaches, other non-branched endovascular techniques, prior repairs, or urgent/emergent cases may not see applicable cost-effectiveness insights.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, ambispective observational study enrolling about 300 adults treated between 2018 and 2025. It includes roughly 200 patients with retrospective data and 100 with prospective data, reflecting real-world decisions rather than random assignments. Patients undergo either open surgical repair or endovascular repair using iliac branch endoprostheses, with follow-up aligned to standard clinical guidelines. The study analyzes outcomes and costs across current practice to understand economic value. Participation is voluntary, and treatment allocation follows usual care rather than randomization.
Why it matters
Potential benefit: If successful, findings could clarify the economic value of iliac branch endoprostheses in aorto-iliac aneurysm repair and inform decision-making for clinicians and payers.
How similar studies have gone: Prior research on endovascular devices and cost-effectiveness in vascular surgery has shown mixed results; this study adds real-world economic data in a branded iliac branch context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) or endovascular repair (with Iliac Branch Endoprosthesis) * Adult patients ≥18 years * Patients able to understand and sign the informed consent approved by the Ethics Committee of San Raffaele Hospital Exclusion Criteria: * Patients treated with a hybrid approach (concomitant open surgical and endovascular treatment) * Patients treated with other endovascular techniques besides branched technology (e.g., physician-modified endografts, parallel grafts) * Patients already submitted to prior open or endovascular repair for aorto-iliac aneurysm/prior aorto iliac aneurysm sac embolization * Patients treated in urgent/emergent setting
Where it's running
-
IRCCS San Raffaele Hospital
Miano, Italy, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.