Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses (ECO-IBE)

Prof. Andrea Kahlberg

Status: Not yet enrolling

Conditions: Aorto-iliac Aneurysm

Treatments: Procedure: endovascular repair; Procedure: open surgical repair

Study type: Observational

Funder types: Other

Identifiers

NCT07096388

ECO-IBE STUDY

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Endovascular repair

Description:

Patients affected by an aorto-iliac aneurysm who received endovascular repair (with Iliac Branch Endoprosthesis)

Treatment:

Procedure: endovascular repair

Open surgical repair

Description:

Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft)

Treatment:

Procedure: open surgical repair