Actively Recruiting
Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-19
200
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating outcomes of thoracic endovascular aortic repair (TEVAR) in patients with compromised distal landing zones (CDLZs) in the descending thoracic aorta. This observational study focuses on complications such as stent graft migration, type 1B endoleaks, and new tears caused by suboptimal distal landing zones, which can lead to further aortic damage. The study aims to compare different approaches for improving the distal landing zone seal to reduce major complications after TEVAR. Participants receive one of several types of stent-graft devices: distal active fixation stent-grafts, distal scallop custom-made stent-grafts, distal Aptus Heli-FX EndoAnchors, or standard thoracic stent-grafts. These devices are designed to improve the durability of TEVAR by enhancing the seal at the distal end of the stent. The study observes and collects data on these different device types to assess their impact on patient outcomes. During the study, participants will be monitored with follow-up evaluations at 3 months to assess the presence of type 1B endoleaks and other complications related to the distal landing zone. Outcomes are measured by imaging and clinical assessments to understand how well each device performs in sealing the aorta. The study is conducted by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and will continue through November 2027.
CONDITIONS
Brief Title
Active Thoracic Compromised Distal LANding in TEvar
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with descending thoracic aortic aneurysms with a maximal aortic diameter greater than 55 mm or rapid growth over 10 mm per year
- Patients presenting with at least 2 features of adverse aortic morphology including distal landing zone length 25 mm or less, distal landing zone diameter 38 mm or more, conical morphology, distal descending thoracic aorta angulation 116° or more, or tortuosity index 1.4 or more
You will not qualify if you...
- Emergency cases including hemodynamic instability at time of enrollment
- Patients with aortic dissection pathology
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo placement of a covered stent in the weakened area of the artery as part of the thoracic endovascular aortic repair.
1 visit (in-person)
Duration - Up to 3 months
Participants are monitored to assess outcomes such as Ib endoleak and recovery after the stent placement.
Follow-up visits at 3 months
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00167
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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