Aorto-iliac Occlusion Treatment With ShorT Unibody aorTic Endograft - ASTUTE Study

Summary

The goal of this multi center prospective observational study is to evaluate the iliac patency rate during the time in patients treated with "AFX (Endologix, Irvine Calif)" unibody stent-graft for aorto-iliac occlusive disease The main question it aims to answer is if The Unibody AFX (Endologix) endograft could be in a large and real-world cohort of patients effective solution for the less-invasive treatment of the aortoiliac occlusive disease (AIOD).

Participants affected by AIOD with an indication of endovascular treatment will be prospectively enrolled and treated as our clinical practice. The requested follow-up did not differ from the one suggested by the most recent guidelines

Conditions

• Occlusive Arterial Disease

Interventions

DEVICE

EVAR off-label use

Normally a femoral access was used, although a brachial approach can be useful for crossing total occlusions. For TASC B and C lesions, predilatation of the iliac lesions is advisable, while for TASC D it is mandatory. In case of total aortic occlusions, the procedure demands that recanalization of the distal aorta occurs as close as possible to the bifurcation.. The key technique is to recanalize from one common iliac artery into the opposing snaring the wire to create a femoral-femoral crossover. The femoral-femoral wire is then replaced with a MPA catheter; the SurePass wire attached to the contralateral limb is then passed through the catheter. The sheath can be placed within 5 cm of the aortic bifurcation, and the AFX can be delivered through the common iliac and aortic occlusion. Predilatation were performed with bilateral 6-8 mm x 150 mm balloons and or progressive dilatators.

Sponsors & Collaborators

• Careggi Hospital

  collaborator OTHER

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  collaborator OTHER

• Azienda Policlinico Umberto I

  collaborator OTHER

• S. Andrea Hospital

  collaborator OTHER

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• Ospedale Policlinico San Martino

  collaborator OTHER

• Azienda Ospedaliero, Universitaria Pisana

  collaborator OTHER

• Azienda Ospedaliera Sant'Anna

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-10

Primary Completion

2024-03-31

Completion

2029-01-31

FDA Device

Yes

Countries

• Italy

Study Locations