Active Thoracic Compromised Distal LANding in TEvar
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 1 Nov 2022
- Expected to end
- 1 Nov 2027
- Type of study
- Observational, 4 groups
- Treatments tested
- Thoracic Endovascular Aortic Repair
- Record updated
- 19 March 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Emergency setting, including hemodynamic instability at time of enrollment
- Patients with aortic dissection pathology
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCSRoma, ItalyContact: Giovanni TinelliTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 4 groups in the trial
- Distal active fixation stent-grafts
Treatment: Thoracic Endovascular Aortic Repair
- Distal scallop stent-grafts
Distal scallop custom-made stent-grafts
Treatment: Thoracic Endovascular Aortic Repair
- Distal Aptus Heli-FX EndoAnchors
Treatment: Thoracic Endovascular Aortic Repair
- Standard stent-grafts
Standard Thoracic stent-graft
Treatment: Thoracic Endovascular Aortic Repair
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones
- Record updated
- 19 March 2025