Active Thoracic Compromised Distal LANding in TEvar

NCT06882967 | Recruiting FDA Device

• 1 other identifier: 5107
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ib Endoleak

  Presence of type Ib endoleak

  Follow-up (at month 3)

Study Arms (4)

Distal active fixation stent-grafts

Distal active fixation stent-grafts

Device: Thoracic Endovascular Aortic Repair

Distal scallop stent-grafts

Distal scallop custom-made stent-grafts

Device: Thoracic Endovascular Aortic Repair

Distal Aptus Heli-FX EndoAnchors

Distal Aptus Heli-FX EndoAnchors

Device: Thoracic Endovascular Aortic Repair

Standard stent-grafts

Standard Thoracic stent-graft

Device: Thoracic Endovascular Aortic Repair

Interventions

Thoracic Endovascular Aortic Repair 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 active fixation stent-grafts; Distal scallop stent-grafts; Standard stent-grafts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with descending thoracic aortic aneurysms (DTAAs) with a maximal aortic diameter \> 55mm or rapid growth (\>10mm / year).

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00167, Italy

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Diseases

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 19, 2025
• Study Start: November 1, 2022
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)