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NCT Number: NCT07096388

Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele Hospital

Miano, Italy, 20132

Location status: Recruiting

Location contact

Andrea kahlberg, Prof

CONTACT

[email protected]

0226437367

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovascular repair

Procedure

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 complications due to its occlusion; they ensure better distal sealing by reducing the rate of type Ib endoleaks. The patient can be treated under local anesthesia and sedation or general anesthesia. Ultrasound-guided percutaneous access to one or both femoral arteries and, if needed, to the axillary or brachial artery is gained.

open surgical repair

Procedure

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 experienced operators due to the location of the iliac arteries. It is a procedure with a high risk of bleeding and mortality, and a high risk of damaging nearby structures such as the ureters and great veins. At the end of the procedure the patient is awake and is usually monitored in the recovery room and then translated to the ward, with fewer than 20% of patients needing Intensive Care Unit (ICU) admission.

Primary outcomes

  1. Comparison of perioperative and late clinical success

    Time frame: 30 days 1 year 2 years

    Analysis of physiological parameters as Freedom from aorto-iliac related death, major adverse events (MAEs), and reintervention

Secondary outcomes

  1. Comparison of cost-effectiveness

    Time frame: 30 days 1 year 2 years

    Measurements of structure, process and outcome relating to both direct and global costs (including major adverse events and reintervention-related costs)

Sponsors and collaborators

Lead sponsor

Prof. Andrea Kahlberg

Other

Registry information

Official study title

Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model

Acronym: ECO-IBE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 31, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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