Treatment of TASC C and D Aortoiliac Lesions

Summary

Background:

The treatment of patients with complex aortoiliac disease (AID), classified as Trans-Atlantic Inter-Society consensus II (TASC) class C and D, presents a dilemma for vascular surgeons. Current guidelines recommend either open surgical reconstruction (OR), hybrid repair (HR) combining iliac stenting with femoral endarterectomy, or total endovascular repair (ER). While traditional OR with aortobifemoral bypass (ABF) is associated with excellent long term patency results, it is associated with significant perioperative morbidity with some studies citing mortality rates of up to 4-8%. 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 mainly in the subset of patients with high surgical risk, given the substantially less perioperative morbidity and mortality compared to OR.

Aim:

The aim of this trial is to evaluate the short, mid-, and long-term results of open repair, hybrid and endovascular repair in the treatment patients with complex, TASC C and D, aortoiliac lesions.

Methodology:

This is a retrospective cohort study planning to include vascular surgery centers from the following countries: Italy, Portugal, Spain, and Serbia. Data will be collected on demographics, baseline comorbidities, anatomy and morphology of the aortoiliac and femoral bifurcation disease, intraoperative, postoperative, and follow-up data. Propensity score analysis will be performed by matching open repair patients in all three groups (open, hybrid, and endovascular repair) controlling for demographics, baseline comorbidities, anatomical and morphological data.

Endpoints:

Primary endpoints are all-cause mortality and the major adverse limb events (major amputation - below and above the knee, new onset acute limb ischaemia, reintervention of the treated arterial segment). The secondary endpoints are the 30-day complications and primary patency.

Conditions

• Peripheral Arterial Disease
• Aortoiliac Occlusive Disease
• Leriche Syndrome
• Peripheral Vascular Disease

Interventions

PROCEDURE

Open surgery

Patients with complex TASC C and D aortoiliac occlusive disease undergoing open surgery: aortobifemoral bypass, crossover bypass, axillobifemoral bypass, aortoiliac endarterectomy, iliofemoral bypass

PROCEDURE

Hybrid repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing simultaneous open surgical femoral artery reconstruction (endarterectomy, bypass, profundoplasty) and stenting of the iliac axis

PROCEDURE

Endovascular repair

Patients with complex TASC C and D aortoiliac occlusive disease undergoing total endovascular repair using different material: bare metal stents (self and balloon expandable), stent-grafts (self and balloon expandable), covered endovascular reconstruction of aortic bifurcation (CERAB), simple plain old balloon angioplasty (POBA)

Sponsors & Collaborators

• University of Belgrade

  collaborator OTHER

• University of Trieste

  collaborator OTHER

• Centro Hospitalar De São João, E.P.E.

  collaborator OTHER

• Clinical Center Nis, University of Nis

  collaborator UNKNOWN

• Clinical Center Novi Sad, University of Novi Sad

  collaborator UNKNOWN

• Institute for Cardiovascular Diseases Dedinje

  collaborator OTHER

• Clinical Centre of Serbia

  lead OTHER

Principal Investigators

• Joao Rocha Neves, MD PhD · Univeristy of Porto

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-01

Primary Completion

2025-05-01

Completion

2025-09-01

Countries

• Serbia

Study Locations