Actively Recruiting

Age: 18Years +
All Genders
NCT06882967

Active Thoracic Compromised Distal LANding in TEvar

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-19

200

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Thoracic endovascular aortic repair (TEVAR) has become the mainstay of aortic intervention for descending thoracic aortic pathology. Its durability hinges on achieving adequate seal in the endograft landing zones (LZs), with the distal LZ largely understudied. Only recently are suboptimal distal LZs receiving attention for their role in major complications including stent graft migration, type 1B endoleaks, and distal stent graft-induced new entry tears, all of which can contribute to further aortic degeneration. The thoracic distal LZ. When a short distal LZ was reported, the distal endoleak rate ranged from 3.5% to 33%. This led to reintervention in 19%, along with coverage of the celiac trunk in more than half of short LZ cases. The objective of this study was to evaluate the outcomes of TEVAR patients with compromised distal landing zone (CDLZs) treated with distal active fixation stent-grafts (DAFs), distal scallop stent-grafts, distal Aptus Heli-FX EndoAnchors, and standard stent-grafts.

CONDITIONS

Official Title

Active Thoracic Compromised Distal LANding in TEvar

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter greater than 55 mm or rapid growth (more than 10 mm per year).
  • Patients presenting with at least 2 features related to adverse aortic morphology, including distal landing zone length 25 mm or less, distal landing zone diameter 38 mm or more, conical landing zone shape, distal descending thoracic aorta angulation 116 degrees or more, or tortuosity index 1.4 or higher.
Not Eligible

You will not qualify if you...

  • Emergency setting including hemodynamic instability at time of enrollment.
  • Patients with aortic dissection pathology.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy, 00167

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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