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

Modified Preloaded System for Renal Arteries in Fenestrated Endografting

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.

Study Overview

• Status: Recruiting
• Conditions: Juxtarenal Aortic Aneurysm; Aortic Aneurysm, Thoracoabdominal; Thoracoabdominal Aortic Aneurysm; Penetrating Aortic Ulcer; Endoleak; Pararenal Aortic Aneurysm; Pseudoaneurysm; Dissection Aortic Aneurysm

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.

• Study Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: Enrico Gallitto, MD, PhD; Phone Number: +393330512143288; Email: enrico.gallitto@gmail.com

Study Locations

• Italy
  • Emilia Romagna
    • Bologna, Emilia Romagna, Italy, 40138
      • Recruiting
      • University of Bologna
      • Contact: Enrico Gallitto, MD, PhD; Phone Number: +390512143288; Email: enrico.gallitto@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Bologna

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Hemorrhage; Aortic Diseases; Postoperative Hemorrhage; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic; Endoleak; Aneurysm, False
• Other Study ID Numbers: MPSRA