Active Thoracic Compromised Distal LANding in TEvar (ATLANTE)

Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Diseases; Thoracic Aortic Aneurysm
• Intervention / Treatment: Device: Thoracic Endovascular Aortic Repair

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00167
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Giovanni Tinelli; Phone Number: 0039 0630157205; Email: giovanni.tinelli@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Distal active fixation stent-grafts	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.
Distal scallop stent-grafts; Distal scallop custom-made stent-grafts	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.
Distal Aptus Heli-FX EndoAnchors	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.
Standard stent-grafts; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ib Endoleak	Presence of type Ib endoleak	Follow-up (at month 3)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aortic Diseases
• Other Study ID Numbers: 5107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes