NCT06882967

Active Thoracic Compromised Distal LANding in TEvar

Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2025-03-19
• Last updated: 2025-03-19

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study