An observational study in Juxtarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm and Pararenal Aortic Aneurysm, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by University of Bologna · Observational
Advanced Endovascular repair of aneurysms and dissections involving thoraco-abdominal (type I-IV) and complex abdominal (juxta and para-renal) aorta is a ground-gaining procedure allowing favorable results in high surgical risk patients. The availability of iliac vessels navigation and the major role of lower leg perfusion in order to decrease the risk of spinal cord ischemia during these complex procedures, led to the development of devices with lower sheaths sizes and to the improvement of the technique with preloaded devices for visceral vessels in order to navigate in hostile anatomies or when an iliac access is not available. The aim of the study is to evaluate in a prospective single center observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries in fenestrated endografting in the routine treatment of paravisceral and thoraco-abdominal aortic pathologies.
Thoracoabdominal aortic aneurysm (TAAA) and complex abdominal aortic aneurysms (AAA) represents an evolving pathology that involves to varying degrees both the descending thoracic aorta and the abdominal aorta. These aneurysms, according to their localization and involvement in the thoracic and abdominal aorta, have been classified according to Crawford into 4 groups (I-IV) for the TAAA and in pararenal/juxtarenal (p/j-AAA) for AAA when a standard endovascular repair is not possible.
The prevalence of these pathologies is currently not well known, but high mortality rates are reported in the population carrying TAAAs and j/p-AAAs that have not undergone surgical treatment, most of which are due to aortic rupture.
Among of the main complications related to TAAA endovascular repair and to complex AAA we can account spinal cord ischemia, lower leg ischemia and logo-operative times, that all can contribute to decrease overall technical and clinical success.
A particular subgroup of TAAAs is represented by post-dissection thoracoabdominal aneurysms (PDTAA), which represents an evolving pathology and one of the main chronic complications in outcomes of acute chronic dissection. In these particular subset of patients, as well as in patient with highly calcified and hostile accesses, the risk of post-operative spinal cord ischemia is higher and the availability of both iliac access navigability is not always possible, leading to technical failure, intraoperative complications and need for adjunctive invasive procedures in high surgical risk patients.
The fenestrated and branched endoprostheses (F/B-EVAR) represent a technology that is now firmly used for the treatment of thoraco-abdominal degenerative aneurysmal pathology in superspecialized centers. Recently, the technology with F/B-EVAR has also been used in the treatment of PDTAA, IMH and PAU, showing satisfactory results. This experience has been carried out in some centers, in the absence, however, of a wider and generalized experience. All these type of endografts are custom-made devices, requiring therefore a lading time for production and delivering before being implanted into the specific patient.
In order to overcome main drawbacks of these procedures, such us long operating time due to fenestrations and vessels cannulation, to avoid bilateral lower limbs ischemia due to large bore introducer sheaths and to accomplish successful delivery even in patient without navigability of both iliac accesses, a modified preloaded system for renal arteries has been developed by Cook (Cook Medical, Bloomington, IN, USA).
The aim of the study is to evaluate in a prospective single center study observational setting, the outcomes, safety and efficacy of the modified preloaded system for renal arteries developed by Cook Medical with bi-port handle system in the field of fenestrated endografting during the routine treatment of thoraco-abdominal and paravisceral abdominal aortic pathologies.
63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.
This study's planned enrollment of 35 is below the median of 100 across 20 observational studies indexed under Aortic Aneurysm, Thoracoabdominal.
Browse Aortic Aneurysm, Thoracoabdominal studies →University of Bologna is the lead sponsor of 158 studies on the registry; 24 are open to participants now.
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All elective patients treated in a single center institution, with the standard of care for thoraco-abdominal and para-juxta-renal abdominal aortic aneurysms using fenestrated/branched custom-made endograft developed by Cook Medical with modified preloaded system for renal arteries.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Technical Success
Successful deployment of custom-made modified endograft, target vessel patency and aneurysm exclusion, in absence of intra-operative mortality.
Time frame: Intra-operative final completion angiography.
Mortality
Assessment of mortality related to procedure
Time frame: Within the first 30-days from the procedure.
Cardiovascular Adverse Events
Cardiopulmonary and renal events related to the procedure.
Time frame: Within the first 30-days from the procedure.
Neurologic Adverse Events
Incidence of Spinal Cord Ischemia (transient/permanent) and Stroke
Time frame: Within the first 30-days from the procedure.
Vessel Instability
Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention
Time frame: Within the first 30-days from the procedure.
Rate of early reintervention
Any re-intervention needed after the type of procedure and the specific reason
Time frame: Within the first 30-days from the procedure.
Overall Survival
Assessment of mortality in the post-operative period
Time frame: Through study completion, an average of 1 year.
Aorta Related Survival
Assessment of mortality in the post-operative period related to aortic procedure or aortic related death.
Time frame: Through study completion, an average of 1 year.
Freedom from reintervention
Time from procedure to the first aortic related/procedure related reintervention
Time frame: Through study completion, an average of 1 year.
Freedom from Vessel Instability
Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention
Time frame: Through study completion, an average of 1 year.
Freedom from Major Endoleaks
Time from procedure to the presence of high-flow endoleak (TypeI/III) and from endoleak that required reintervention
Time frame: Through study completion, an average of 1 year.
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