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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Jesse Manunga, MD
Study ID
NCT05531084
Status
Not Yet Recruiting

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Conditions

  • Aortic Aneurysm
  • Failed Previous Infrarenal Repairs (Failed EVAR)
  • Juxtarenal Aortic Aneurysm
  • Pararenal Aneurysm
  • Thoracoabdominal Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Oct 1, 2022
Status verified
Oct 2022
Primary completion
Oct 1, 2027
Completion
Oct 1, 2032

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Thoracoabdominal aortic aneurysm extent I-III
    Thoracoabdominal aortic aneurysm extent I-III (proximal seal can be from the left carotid artery to directly after the left subclavian artery):
  • Experimental: Failed EVAR
    Failed EVAR (defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss)/juxtarenal/Pararenal/paravisceral/thoracoabdominal aortic aneurysm extent IV-V:

Primary Outcome Measure

Prevention of aortic aneurysm related mortality and all cause mortality post intervention [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407
JoAnne Goldman
[email protected]
612-863-3833

Find similar trials in Minneapolis, MN

By research site
Minneapolis Heart Institute Foundation· Minneapolis, MN

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