Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: endovascular repair, open surgical repair.
- Who it may be relevant to
- Registry conditions: Aorto-iliac Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model
Overview
The study is a multi-center, voluntary observational study on an ambispective cohort of patients treated between January 2018 and December 2025.The study aims to enroll 300 patients (around 200 patients in the retrospective cohort and 100 patients in the prospective cohort). The study will include adult patients (≥ 18 years) of either sex submitted to open surgical repair or endovascular repair of an aorto-iliac aneurysm.The procedures and clinical evaluation included in this study correspond to current clinical practice. The assignment of the patient to a given diagnostic and/or therapeutic procedure is not linked to random allocation but is part of the ordinary therapeutic strategy provided for that patient; full freedom of choice as regards to the allocation of the patient to the diagnostic and therapeutic procedures is guaranteed for each case. Follow-up visits substantially correspond to current clinical practice or to the requirements of national and/or international guidelines. The administration of questionnaires, interviews, diaries, surveys of health economics and pharmacoeconomics, subjective assessments by the patient on their state of health, assessment scales and blood chemistry tests, the use of which is justified by the rationale of the study. The objectives of the study are the comparison of perioperative and late clinical success of repair procedure and comparison of cost-effectiveness of two precedures.
Interventions
- Procedure endovascular repair
at first the iliac pathology main endovascular treatment was the graft stenting extended along the common and the external iliac artery with the embolisation of the internal iliac artery, with an high risk of pelvic ischemic complications, bowel ischemia, spinal cord ischemia, buttock claudication, erectile dysfunction. Nowadays, off-the-shelf endografts with a special design, the Iliac Branch Endoprosthesis, are available. These grafts, which preserve the hypogastric artery, avoiding complicati - Procedure open surgical repair
in case of surgical repair of aorto-iliac aneurysms, general anesthesia is required. Access to the aorta can be achieved through a transperitoneal or retroperitoneal approach. A bifurcated graft is usually used for reconstruction as it is more similar to the native anatomical conformation, but it is not the only option. Although not mandatory, it may be necessary to revascularize one or both internal iliac arteries. This is a very complex surgical technique, challenging even for the most experie
Primary outcome measures
- Comparison of perioperative and late clinical success [Time frame: 30 days 1 year 2 years]
Secondary outcome measures (1)
- Comparison of cost-effectiveness [Time frame: 30 days 1 year 2 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele Hospital — Miano
Identifiers
NCT: NCT07096388 · ECO-IBE STUDY