NCT06882967 Active Thoracic Compromised Distal LANding in TEvar
| NCT ID | NCT06882967 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Thoracic Aortic Aneurysm |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-11-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT06882967 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thoracic Aortic Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06882967 currently recruiting?
Yes, NCT06882967 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fondazione Policlinico Universitario Agostino Gemelli IRCCS to inquire about joining.
Where is the NCT06882967 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT06882967 clinical trial?
NCT06882967 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 200 participants.