Active Thoracic Compromised Distal LANding in TEvar
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency setting, including hemodynamic instability at time of enrollment
Patients with aortic dissection pathology
Trial 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
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Thoracic Endovascular Aortic Repair
DevicePlacement of a covered stent (a metal mesh tube with a layer of fabric) into the weakened area of the artery.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: Distal active fixation stent-grafts1 intervention
Group B: Distal scallop stent-grafts1 intervention
Group C: Distal Aptus Heli-FX EndoAnchors1 intervention
Group D: Standard stent-grafts1 intervention
Trial outcomes
Primary outcomes
1
Ib Endoleak
Presence of type Ib endoleak
Time frame
Follow-up (at month 3)Sponsors and contacts
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Source ClinicalTrials.gov