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

NCT05224219 | Unknown

• 1 other identifier: MPSRA
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Cardiovascular Adverse Events

  Within the first 30-days from the procedure.

• Neurologic Adverse Events

  Within the first 30-days from the procedure.

• Vessel Instability

  Within the first 30-days from the procedure.

• Rate of early reintervention

  Within the first 30-days from the procedure.

• Overall Survival

  Through study completion, an average of 1 year.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

University of Bologna

Bologna, Emilia-Romagna, 40138, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 32063442 RESULT

• 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.

  PMID: 28888759 RESULT

• 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.

  PMID: 28342523 RESULT

• 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.

  PMID: 30385148 RESULT

• 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.

  PMID: 32686037 RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Dissection; Penetrating Atherosclerotic Ulcer; Endoleak; Aneurysm, False

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Central Study Contacts

Enrico Gallitto, MD, PhD

CONTACT

+393330512143288; enrico.gallitto@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 4, 2022
• Study Start: January 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

IT (1)