Active Thoracic Compromised Distal LANding in TEvar

Recruiting now

Conditions studied: Thoracic Aortic Aneurysm, Aortic Diseases

In brief

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.

Key facts

Study ID: NCT06882967
Run by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
People needed: 200
Starts: 2022-11-01
Expected to finish: 2027-11-01
Last updated by the study team: 2025-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter > 55mm or rapid growth (>10mm / year).
Patients presenting with at least 2 cognizable features related to an adverse aortic morphology will be considered for inclusion. The following features will be evaluated for the inclusion: distal LZ length ≤25-mm, distal LZ diameter ≥38-mm, LZ conical morphology, distal descending thoracic aorta angulation ≤116° or tortuosity index ≥1.4

You may not qualify if…

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

Where it is running

Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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