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NOT YET RECRUITING
NCT05531084
NA

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

Sponsor: Jesse Manunga, MD

View on ClinicalTrials.gov

Summary

The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).

Official title: Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2022-10-01

Completion Date

2032-10-01

Last Updated

2022-10-06

Healthy Volunteers

No

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.

Locations (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States