Active Thoracic Compromised Distal LANding in TEvar (ATLANTE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Aortic Diseases; Thoracic Aortic Aneurysm

Treatments: Device: Thoracic Endovascular Aortic Repair

Study type: Observational

Funder types: Other

Identifiers

NCT06882967

5107

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 4 patient groups

Distal active fixation stent-grafts

Description:

Distal active fixation stent-grafts

Treatment:

Device: Thoracic Endovascular Aortic Repair

Distal scallop stent-grafts

Description:

Distal scallop custom-made stent-grafts

Treatment:

Device: Thoracic Endovascular Aortic Repair

Distal Aptus Heli-FX EndoAnchors

Description:

Distal Aptus Heli-FX EndoAnchors

Treatment:

Device: Thoracic Endovascular Aortic Repair

Standard stent-grafts

Description:

Standard Thoracic stent-graft

Treatment:

Device: Thoracic Endovascular Aortic Repair