RecruitingNCT06882967

Active Thoracic Compromised Distal LANding in TEvar

Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

200 participants

Start Date

Nov 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter > 55mm or rapid growth (>10mm / year).

Exclusion Criteria2

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

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Interventions

DEVICEThoracic Endovascular Aortic Repair

Placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

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NCT06882967


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