Status:
UNKNOWN
Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)
Lead Sponsor:
University of Bologna
Conditions:
Juxtarenal Aortic Aneurysm
Thoracoabdominal Aortic Aneurysm
Eligibility:
All Genders
18-100 years
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 re...
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 abdomi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05224219
Start Date
January 1 2019
End Date
December 1 2022
Last Update
February 22 2022
Active Locations (1)
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1
University of Bologna
Bologna, Emilia-Romagna, Italy, 40138