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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Aortoiliac Atherosclerosis Aortoiliac Occlusive Disease Aortoiliac Atherosclerosis With Gangrene Aortoiliac Atherosclerosis Without Gangrene Aortoiliac Obstruction Peripheral Arterial Disease Peripheral Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease

Chronic limb-threatening ischemia or claudicants due to extensive Aortoiliac Occlusive Disease (AIOD), particularly in Trans-Atlantic Inter-Society Consensus II (TASC-II) type C and D lesions

Aortobifemoral bypass

Intervention Type PROCEDURE

Open surgery with aortic and iliac reconstruction

aortoiliac stenting

Intervention Type PROCEDURE

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

Interventions

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Aortobifemoral bypass

Open surgery with aortic and iliac reconstruction

Intervention Type PROCEDURE

aortoiliac stenting

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

Intervention Type PROCEDURE

Other Intervention Names

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aortobiliac bypass Percutaneous transluminal aortoiliac stenting; Endovascular treatment of aortoiliac occlusive disease

Eligibility Criteria

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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