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

Not yet recruiting

• Conditions: Aortoiliac Occlusive Disease; Aortoiliac Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Aortoiliac Atherosclerosis With Gangrene; Aortoiliac Obstruction; Aortoiliac Atherosclerosis Without Gangrene
• Interventions: Procedure: Aortobifemoral bypass; Procedure: aortoiliac stenting

• Registration Number: NCT06260475
• Lead Sponsor: Universidade do Porto

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).

Study Timeline

• Study First Submitted: 2023-12-10
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Study Start: 2024-03-01
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease	Aortobifemoral bypass	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
Patients with symptomatic peripheral artery disease and aortoiliac obstrutive disease	aortoiliac stenting	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

Primary Outcome Measures

Name	Time	Method
acute myorcardial infartion	through study completion, an average of 3 years	According to the 4th definition of Myocardial infarction
Major Amputation	through study completion, an average of 3 years	Amputation above the ankle
Cardiovascular Death	through study completion, an average of 3 years	Death from cardiovascular disease

Secondary Outcome Measures

Name	Time	Method
Major Adverse Limb Events	through study completion, an average of 3 years	Amputation above the ankle, arterial thrombosis of the limb, binary restenosis
Major adverse cardiovascular events	through study completion, an average of 3 years	acute myocardial infarction; acute heart faillure, cardiovascular death, coronary reintervention
Death	through study completion, an average of 3 years	Diagnosed by a physician

Trial Locations

Locations (2)

Centro Hospitalar Universitário de São João, EPE; 🇵🇹 Porto, Portugal

Faculdade de Medicina da Universidade do Porto; 🇵🇹 Porto, Portugal