RecruitingNCT06253312

Treatment of TASC C and D Aortoiliac Lesions

Comparison of Open Surgery, Hybrid and Endovascular Repair for Complex TASC C/D Aortoiliac Lesions


Sponsor

Clinical Centre of Serbia

Enrollment

900 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria2

  • All patients (over 18 years of age) with a history of atherosclerotic peripheral arterial disease treated between 1st January 2015 and 1st January 2022
  • All management strategies will be included (endovascular, hybrid, and open)

Exclusion Criteria7

  • Patients who are pregnant
  • Patients who are under 18 years of age
  • Patients who have acute limb ischemia or acute on chronic ischemia
  • Non-atherosclerotic origin of disease: cyclist disease, trauma, dissection
  • Patients who were treated in conservative manner
  • Patients who underwent primary major amputation
  • Patients with limited life expectancy (less than 2 years)

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Interventions

PROCEDUREOpen surgery

Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass

PROCEDUREHybrid repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis

PROCEDUREEndovascular repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)


Locations(1)

Clinical Center of Serbia

Belgrade, Serbia

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NCT06253312


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