Clinical trial NCT05224219: Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)
Official title: Modified Preloaded System for Renal Arteries in Fenestrated Endografting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Juxtarenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Pararenal Aortic Aneurysm
Aortic Aneurysm, Thoracoabdominal
Dissection Aortic Aneurysm
Penetrating Aortic Ulcer
Endoleak
Pseudoaneurysm
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Technical Success
timeFrame: Intra-operative final completion angiography.
measure: Mortality
timeFrame: Within the first 30-days from the procedure.
Secondary outcomes:
measure: Cardiovascular Adverse Events
timeFrame: Within the first 30-days from the procedure.
measure: Neurologic Adverse Events
timeFrame: Within the first 30-days from the procedure.
measure: Vessel Instability
timeFrame: Within the first 30-days from the procedure.
measure: Rate of early reintervention
timeFrame: Within the first 30-days from the procedure.
measure: Overall Survival
timeFrame: Through study completion, an average of 1 year.
measure: Aorta Related Survival
timeFrame: Through study completion, an average of 1 year.
measure: Freedom from reintervention
timeFrame: Through study completion, an average of 1 year.
measure: Freedom from Vessel Instability
timeFrame: Through study completion, an average of 1 year.
measure: Freedom from Major Endoleaks
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna
state: Emilia Romagna
Study officials:
References:
citation: Gallitto E, Faggioli G, Spath P, Pini R, Mascoli C, Ancetti S, Stella A, Abualhin M, Gargiulo M. The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft. J Vasc Surg. 2020 Jul;72(1):16-24. doi: 10.1016/j.jvs.2019.08.273. Epub 2020 Feb 13.
citation: Gallitto E, Gargiulo M, Faggioli G, Pini R, Mascoli C, Freyrie A, Ancetti S, Stella A. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair. J Vasc Surg. 2017 Dec;66(6):1659-1667. doi: 10.1016/j.jvs.2017.04.063. Epub 2017 Sep 6.
citation: Maurel B, Resch T, Spear R, Roeder B, Bracale UM, Haulon S, Mastracci TM. Early experience with a modified preloaded system for fenestrated endovascular aortic repair. J Vasc Surg. 2017 Apr;65(4):972-980. doi: 10.1016/j.jvs.2016.09.045.
citation: Spanos K, Kolbel T, Kubitz JC, Wipper S, Konstantinou N, Heidemann F, Rohlffs F, Debus SE, Tsilimparis N. Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms. J Vasc Surg. 2019 Feb;69(2):357-366. doi: 10.1016/j.jvs.2018.05.216. Epub 2018 Oct 29.
citation: Bertoglio L, Loschi D, Grandi A, Melloni A, Bilman V, Melissano G, Chiesa R. Early Limb Reperfusion Using Routinely Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures. Cardiovasc Intervent Radiol. 2020 Dec;43(12):1868-1880. doi: 10.1007/s00270-020-02596-1. Epub 2020 Jul 19.