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).
Age: ≥ 18 years old
American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
SVS/AAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.
American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.
Age: < 18 years old
Does not meet the above inclusion criteria
Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery
Single group
Surgeon-Modified fenestrated stent grafts using Cook Zenith Platform (Zfen, TX2, Alpha Thoracic Endovascular Graft and Zenith Flex)
DeviceDepending 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.
Prevention of aortic aneurysm related mortality and all cause mortality post intervention
Primary outcome criteria: * Mortality related to primary aortic disease and intervention * All-cause mortality post intervention
Issues associated with disease progression, branched instability, endoleak and other disabling complications as evaluated on post-operative follow up and radiographic images.
Secondary outcome criteria (as evidenced on follow up imaging and laboratory tests): * Evidence of aortic disease progression (aneurysm growth \>/=5 mm)
Endoleak
presence of any endoleak requiring intervention
Target vessels instability resulting in adverse events to the patient
* mesenteric ischemia * renal failure
procedure related complication
* stroke * Myocardial infarction * Paraplegia
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Jesse Manunga, MD
Lead sponsor
Minneapolis Heart Institute Foundation
Sponsor institution
Minneapolis Heart Institute Foundation
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
