Active Thoracic Compromised Distal LANding in TEvar
NCT06882967 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2025-03-19
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.
Conditions
- Thoracic Aortic Aneurysm
- Aortic Diseases
Interventions
- DEVICE
-
Thoracic Endovascular Aortic Repair
Placement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.
Sponsors & Collaborators
-
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2025-11-01
- Completion
- 2027-11-01
- FDA Device
- Yes
Countries
- Italy
Study Locations
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