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临床试验/NCT06260475
NCT06260475尚未招募不适用

IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions

Universidade do Porto2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
2
主要终点
acute myorcardial infartion

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Synchronous aortoiliac aneurysmatic/ectasic disease (aorta AP diameter >25 mm)

结局指标

主要结局

acute myorcardial infartion

时间窗: through study completion, an average of 3 years

According to the 4th definition of Myocardial infarction

Major Amputation

时间窗: through study completion, an average of 3 years

Amputation above the ankle

Cardiovascular Death

时间窗: through study completion, an average of 3 years

Death from cardiovascular disease

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

João Rocha Neves

Clinical Professor

Universidade do Porto

研究点 (2)

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