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Active Thoracic Compromised Distal LANding in TEvar

Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06882967
Acronym
ATLANTE
Enrollment
200
Registered
2025-03-19
Start date
2022-11-01
Completion date
2027-11-01
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Diseases, Thoracic Aortic Aneurysm

Brief 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.

Interventions

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Ib EndoleakFollow-up (at month 3)Presence of type Ib endoleak

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026