Aorto-iliac AneurysmECO-IBENCT07096388
Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses
An observational study of Aorto-iliac Aneurysm, run by Prof. Andrea Kahlberg at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-iliac Aneurysm
- What is being tested?
- endovascular repair and open surgical repair
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2026to 1 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by an aorto-iliac aneurysm
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Hospital
Miano, Italy, 20132
Andrea kahlberg, Prof, 0226437367, kahlberg.andrea@hsr.it
About this study
Official title: Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model
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.
- Conditions
- Aorto-iliac Aneurysm
- Being tested
- endovascular repair, open surgical repair
- Keywords
- endovascular repair, aorto-iliac aneurysm, iliac branch endoprotheses, open surgical repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endovascular repairProcedure or surgery
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 repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular repair | Patients affected by an aorto-iliac aneurysm who received endovascular repair (with Iliac Branch Endoprosthesis) Receives: Procedure: endovascular repair | |
| Open surgical repair | Patients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) Receives: Procedure: open surgical repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of perioperative and late clinical success
Analysis of physiological parameters as Freedom from aorto-iliac related death, major adverse events (MAEs), and reintervention
Measured: 30 days 1 year 2 years
Secondary outcomes (1)
Comparison of cost-effectiveness
Measurements of structure, process and outcome relating to both direct and global costs (including major adverse events and reintervention-related costs)
Measured: 30 days 1 year 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start28 Apr 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-iliac AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Andrea Kahlberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Andrea Kahlberg, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096388
- Sponsor's protocol ID
- ECO-IBE STUDY
- Acronym
- ECO-IBE
- Status last verified
- Sep 2026
- First submitted
- 24 Jul 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Cost-Effectiveness Of Iliac Branch Endoprostheses: A Multi-Center, Retrospective-Prospective, Observational Study/ Eunet-Hta Core Model
- ClinicalTrials.gov ID
- NCT07096388
- Acronym / sponsor ID
- ECO-IBE / ECO-IBE STUDY
- Conditions
- Aorto-iliac Aneurysm
- Keywords
- endovascular repair, aorto-iliac aneurysm, iliac branch endoprotheses, open surgical repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Prof. Andrea KahlbergUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular repair | – | Procedure: endovascular repairPatients affected by an aorto-iliac aneurysm who received endovascular repair (with Iliac Branch Endoprosthesis) |
| Open surgical repair | – | Procedure: open surgical repairPatients affected by an aorto-iliac aneurysm who received an elective open surgical repair (aneurysmectomy and aortic reconstruction with a surgical graft) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by an aorto-iliac aneurysm
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endovascular repairat 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. | Procedure or surgery | Endovascular repair |
| open surgical repairin 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. | Procedure or surgery | Open surgical repair |
Primary outcome
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
1 secondary outcome
Comparison of cost-effectiveness
Time frame: 30 days 1 year 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aorto-iliac Aneurysm, run by Prof. Andrea Kahlberg at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of perioperative and late clinical success (time frame: 30 days 1 year 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.