Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Modified Preloaded System for Renal Arteries in Fenestrated Endografting

Conditions
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Juxtarenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Aortic Aneurysm, Thoracoabdominal, Dissection Aortic Aneurysm, Penetrating Aortic Ulcer, Endoleak, Pseudoaneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of thoraco-abdominal or complex abdominal aortic aneurysm confirmed by a Computed tomography Angiography (CTA). Etiologies will be degenerative aneurysms, inflammatory aneurysms, chronic post-dissectional aneurysms, penetrating aortic ulcers, failure of prior surgical or endovascular repair. Elective aneurysmal repair of patient with maximum diameter greater than 55 mm, or fast growing, or symptomatic aneurysms. Endovascular repair performed using custom-made fenestrated and/or branched endografting with presence of modified preloaded system with modified handle and preloaded catheters for visceral vessels cannulation. Exclusion Criteria: Patients submitted to advanced fenestrated and branched endovascular repair with other grafts besides the Cook Medical custom-made endograft or without modified handle preloaded delivery system. Physician-modified devices Patient treated with hybrid and/or open technique as well as parallel grafts (such as chimney/snorkel/periscope) Patient treated as emergent/urgent patients or aneurysmal rupture Patient who can not wait for the lead time required for endograft production and delivery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Successful deployment of custom-made modified endograft, target vessel patency and aneurysm exclusion, in absence of intra-operative mortality. | Intra-operative final completion angiography. | 
| Mortality | Assessment of mortality related to procedure | Within the first 30-days from the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Adverse Events | Cardiopulmonary and renal events related to the procedure. | Within the first 30-days from the procedure. | 
| Neurologic Adverse Events | Incidence of Spinal Cord Ischemia (transient/permanent) and Stroke | Within the first 30-days from the procedure. | 
| Vessel Instability | Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention | 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 | Within the first 30-days from the procedure. | 
| Overall Survival | Assessment of mortality in the post-operative period | 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. | Through study completion, an average of 1 year. | 
| Freedom from reintervention | Time from procedure to the first aortic related/procedure related reintervention | Through study completion, an average of 1 year. | 
| Freedom from Vessel Instability | Target vessel patency and absence of stenosis, endoleak, occlusion, need for reintervention | 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 | Through study completion, an average of 1 year. |