An observational study in Thoracic Aortic Aneurysm and Aortic Diseases, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
131 studies on the registry are indexed under Aortic Aneurysm, Thoracic; 33 are open to participants now.
This study's planned enrollment of 200 is above the median of 154 across 65 observational studies indexed under Aortic Aneurysm, Thoracic.
Browse Aortic Aneurysm, Thoracic studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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All consecutive patients with compromised distal landing zone undergoing Thoracic Endovascular Aortic Repair in patients with distal active fixation stent-grafts, distal scallop stent-grafts, distal EndoAnchors, and standard stent-grafts in selected high volume aortic centers will be enrolled retrospectively with a prospective database
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Exclusion Criteria:
Distal active fixation stent-grafts
Device: Thoracic Endovascular Aortic Repair
Distal scallop custom-made stent-grafts
Device: Thoracic Endovascular Aortic Repair
Distal Aptus Heli-FX EndoAnchors
Device: Thoracic Endovascular Aortic Repair
Standard Thoracic stent-graft
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.
Ib Endoleak
Presence of type Ib endoleak
Time frame: Follow-up (at month 3)
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Nov 2025, 36 months after the start.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS →