Not Yet RecruitingNot Applicable

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

United States25 participantsStarted 2022-10-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Minimum neck length of 20 mm
✓. Diameter in the range of 20 mm - 38 mm
✓. Angle less than 60 degrees relative to the axis of the aneurysm
✓. Angle less than 60 degrees relative to the axis of the suprarenal aorta

Exclusion criteria

✕. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
✕. Proximal neck length ≤20 mm
✕. Proximal neck, measured outer wall to outer wall on a sectional image (CT)
✕. For use of Zenith Fenestrated: diameter \>32 mm or \<18 mm
✕. For use of Zenith Alpha Thoracic: diameter \>38 mm or \<18 mm (for proximal and distal neck diameter)
✕. Zenith TX2 Dissection Endovascular graft: diameter 38 mm or \<18 mm
✕. Zenith Flex AAA endovascular graft: diameter \>32 mm or \< 18 mm
✕. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm

What they're measuring

Prevention of aortic aneurysm related mortality and all cause mortality post intervention

Timeframe: 5 years

Trial details

NCT IDNCT05531084

SponsorJesse Manunga, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10-01

Contact for this trial

Jesse Manunga, MD, FSVS, FACS

612-863-6800 jesse.manunga@allina.com

View on ClinicalTrials.gov More Thoracoabdominal Aneurysm trials