Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms

NANot yet recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 1, 2022

Primary Completion Date

October 1, 2027

Study Completion Date

October 1, 2032

Conditions
Thoracoabdominal AneurysmJuxtarenal Aortic AneurysmPararenal AneurysmAortic AneurysmFailed Previous Infrarenal Repairs (Failed EVAR)
Interventions
DEVICE

Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)

Depending on the location of the aneurysm, patients with failed EVAR and complex aortic pathology requiring fenestrated and branched endovascular repair will be treated with physician-modified Cook Zenith devices (Zenith Flex, Zenith Fenestrated stent graft (Zfen), Cook Alpha Thoracic Endovascular Graft, Cook dissection TX2), and their associated commercially approved ancillary components.

Trial Locations (1)

55407

Minneapolis Heart Institute Foundation, Minneapolis

All Listed Sponsors
collaborator

Minneapolis Heart Institute Foundation

OTHER

lead

Jesse Manunga, MD

OTHER

NCT05531084 - Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms | Biotech Hunter | Biotech Hunter