Active Thoracic Compromised Distal LANding in TEvar (ATLANTE)

March 15, 2025 updated by: TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Follow-up (at month 3)
Presence of type Ib endoleak
Follow-up (at month 3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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