Evaluating outcomes of thoracic aortic repair in patients with compromised landing zones
Official title: Thoracic Endovascular Aortic Repair in Compromised Distal Landing Zones
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06882967 · Data updated 2026-11-12
This study is testing different stent-graft options for patients with aortic aneurysms who have tricky anatomy to see if they can prevent complications after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | November 1, 2025 |
| Study ends | November 1, 2027 |
| Registry record updated | March 19, 2025 |
| Trial ID | NCT06882967 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with descending thoracic aortic aneurysms greater than 55mm in diameter or those experiencing rapid growth, along with specific adverse morphological features.
✕Probably not a fit
Patients in emergency settings or those with aortic dissection pathology may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on patients undergoing thoracic endovascular aortic repair (TEVAR) for descending thoracic aortic aneurysms, particularly those with compromised distal landing zones (CDLZs). It aims to assess the effectiveness of various stent-graft interventions, including distal active fixation stent-grafts and Aptus Heli-FX EndoAnchors, in preventing complications such as stent graft migration and endoleaks. The study will evaluate outcomes based on specific morphological features of the aorta that may affect the success of the repair. By analyzing these outcomes, the study seeks to improve the management of patients with challenging aortic anatomies.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing TEVAR.
How similar studies have gone: While there is limited data on the specific interventions being tested, the focus on compromised landing zones in TEVAR is gaining attention, suggesting potential for meaningful advancements.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Rm, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.