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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
View:

• 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)

Locations
Other Locations
Serbia
Clinical Center of Serbia
RECRUITING
Belgrade
Contact Information
Primary
Petar Zlatanovic, MD FEBVS
petar91goldy@gmail.com
+381644961020
Backup
Mario D'Oria, MD PhD
mario.doria88@outlook.com
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 900
Treatments
Open surgery
Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass
Hybrid 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
Endovascular 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)
Sponsors
Collaborators: Clinical Center Novi Sad, University of Novi Sad, Clinical Center Nis, University of Nis, University of Belgrade, University of Trieste, Centro Hospitalar De São João, E.P.E., Institute for Cardiovascular Diseases Dedinje
Leads: Clinical Centre of Serbia

This content was sourced from clinicaltrials.gov

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