IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortoiliac Atherosclerosis
- Sponsor
- Universidade do Porto
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- acute myorcardial infartion
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Detailed Description
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).
Investigators
João Rocha Neves
Clinical Professor
Universidade do Porto
Eligibility Criteria
Inclusion Criteria
- •Patients with peripheral arterial/atherosclerotic disease of the aorto-iliac sector undergoing direct, hybrid or endovascular surgical correction with TransAtlantic Inter-Society Consensus (TASC II) type D classification(12).
- •Age \>18 years old
Exclusion Criteria
- •Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter \>25 mm)
Outcomes
Primary Outcomes
acute myorcardial infartion
Time Frame: through study completion, an average of 3 years
According to the 4th definition of Myocardial infarction
Major Amputation
Time Frame: through study completion, an average of 3 years
Amputation above the ankle
Cardiovascular Death
Time Frame: through study completion, an average of 3 years
Death from cardiovascular disease
Secondary Outcomes
- Major Adverse Limb Events(through study completion, an average of 3 years)
- Major adverse cardiovascular events(through study completion, an average of 3 years)
- Death(through study completion, an average of 3 years)