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

NCT05531084 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-06

No results posted yet for this study

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).

Conditions

  • Thoracoabdominal Aneurysm
  • Juxtarenal Aortic Aneurysm
  • Pararenal Aneurysm
  • Aortic Aneurysm
  • Failed 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.

Sponsors & Collaborators

  • Minneapolis Heart Institute Foundation

    collaborator OTHER

  • Jesse Manunga, MD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2027-10-01
Completion
2032-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531084 on ClinicalTrials.gov