Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.

• Aneurysm with a history of growth ≥ 0.5 cm per year.

• Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.

• Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.

• Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.

Locations
United States
Minnesota
Mayo Clinic
ACTIVE_NOT_RECRUITING
Rochester
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Safa Savadi Osgouei, MD
Safa.savadiosgouei@uth.tmc.edu
(713) 486-5361
Time Frame
Start Date: 2014-03
Estimated Completion Date: 2030-05
Participants
Target number of participants: 530
Treatments
Experimental: Thoracoabdominal Aortic Aneurysm Arm
The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Experimental: Aortic Arch Aneurysm Arm
Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.
Sponsors
Collaborators: William Cook Australia
Leads: Gustavo Oderich

This content was sourced from clinicaltrials.gov