Active Thoracic Compromised Distal LANding in TEvar

NCT ID: NCT06882967

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2027-11-01

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.

Conditions

Thoracic Aortic Aneurysm; Aortic Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Distal active fixation stent-grafts

Distal active fixation stent-grafts

Thoracic Endovascular Aortic Repair

Intervention Type: DEVICE

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

Thoracic Endovascular Aortic Repair

Intervention Type: DEVICE

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

Distal Aptus Heli-FX EndoAnchors

Thoracic Endovascular Aortic Repair

Intervention Type: DEVICE

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

Thoracic Endovascular Aortic Repair

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

TINELLI GIOVANNI

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanni Tinelli

Role: primary

giovanni.tinelli@policlinicogemelli.it

0039 0630157205

Other Identifiers

5107

Identifier Type: -

Identifier Source: org_study_id