This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II
Open surgery repair with Aortobifemoral Bypass (ABF) remains the gold standard revascularization technique in patients with lifestyle-limiting intermittent claudication (IC) and chronic limb-threatening ischemia due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type D lesions The ABF procedure has proven safe, effective, and durable, particularly considering its high long-term patency rates (85%-90% at five years and 75%-80% at ten years) despite its significant peri-operative associated morbidity (1). On the other hand, endovascular treatment (EVT) offers an attractive alternative with durable results (four- or 5-year primary and secondary patency rates ranged from 60% to 86% and 80% to 98%, respectively), especially in less extensive AIOD, while also providing less perioperative morbidity, making it generally preferable for patients with more severe comorbid conditions. Thus, surgical approaches to extensive AIOD have changed considerably over the last years, primarily due to increased EVT, particularly with the uncovered aortoiliac stenting (AIS). While TASC II provides an anatomical framework to compare therapeutic techniques, 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. It is attractive for patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to ABF This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II).
Study Type
OBSERVATIONAL
Enrollment
500
Open surgery with aortic and iliac reconstruction
Endovascular reconstruction of aortic and iliac arterial obstruction: Balloon angioplasty may be performed initially to dilate the narrowed segment of the iliac artery. Subsequently, a stent delivery system is advanced over the wire and positioned across the lesion. The stent is deployed under fluoroscopic guidance to expand and scaffold the diseased artery, restoring blood flow. Vascular - iliac dedicated Stent - any brand
Centro Hospitalar Universitário de São João, EPE
Porto, Portugal
Faculdade de Medicina da Universidade do Porto
Porto, Portugal
Major Amputation
Amputation above the ankle
Time frame: through study completion, an average of 3 years
Cardiovascular Death
Death from cardiovascular disease
Time frame: through study completion, an average of 3 years
acute myorcardial infartion
According to the 4th definition of Myocardial infarction
Time frame: through study completion, an average of 3 years
Major Adverse Limb Events
Amputation above the ankle, arterial thrombosis of the limb, binary restenosis
Time frame: through study completion, an average of 3 years
Major adverse cardiovascular events
acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention
Time frame: through study completion, an average of 3 years
Death
Diagnosed by a physician
Time frame: through study completion, an average of 3 years
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