Actively Recruiting
Treatment of TASC C and D Aortoiliac Lesions
Led by Clinical Centre of Serbia · Updated on 2024-08-23
900
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
C
Clinical Centre of Serbia
Lead Sponsor
U
University of Belgrade
Collaborating Sponsor
AI-Summary
What this Trial Is About
Background: The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. The advancement of endovascular techniques has led to many trials suggesting that endovascular management of TASC II C and D lesions is a potential alternative treatment to open strategies mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR. Aim: The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions. Methodology: This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data. Endpoints: Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.
CONDITIONS
Official Title
Treatment of TASC C and D Aortoiliac Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years old with a history of atherosclerotic peripheral arterial disease treated between January 1, 2015 and January 1, 2022
- Patients treated with any management strategy including endovascular, hybrid, or open repair
You will not qualify if you...
- Patients who are pregnant
- Patients under 18 years old
- Patients with acute limb ischemia or acute on chronic ischemia
- Patients with non-atherosclerotic disease causes such as cyclist disease, trauma, or dissection
- Patients treated conservatively without surgery or intervention
- Patients who had a primary major amputation
- Patients with a life expectancy of less than 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
Research Team
P
Petar Zlatanovic, MD FEBVS
CONTACT
M
Mario D'Oria, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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