CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Baylor College of Medicine
Study ID
NCT02089607
Status
Recruiting
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Conditions

  • Aortic Arch Aneurysm
  • Aortic Arch Dissection
  • Complex Abdominal Aortic Aneurysm
  • Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

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

Interventions

  • CAAA and TAAA Arm — DEVICE
    The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). One or more than one of the study devices including the Zenith® Fenestrated AAA Endovascular Graft, Zenith® t-Branch Endovascular Graft, Patient-Specific Thoracoabdominal Graft, Patient-Specific Distal Bifurcated Component, and Zenith® Branch Endovascular Graft-Iliac Bifurcation will be implanted. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
  • Aortic Arch Aneurysm Arm — DEVICE
    The Zenith® Arch Branch Endovascular Graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2032

Study Design

Enrollment
760 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Complex Abdominal (CAAA) and Thoracoabdominal Aortic Aneurysm (TAAA) Arm
    The CAAA and TAAA study arm will include 700 patients treated by endovascular aortic repair of CAAAs and TAAAs (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, with or without concomitant unilateral or bilateral iliac artery aneurysms treated by iliac branch devices. 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 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 60 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 CAAAs, TAAAs 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.

Primary Outcome Measure

Number of subjects who have died at 30 days post treatment [ Time Frame: 30 days post treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-
Baylor College of MedicineHoustonTexas77030
Ying Huang, MD, PhD
[email protected]
832-355-9034
Bruno P Schmid, MD
[email protected]
832-355-9246
Gustavo S. Oderich, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at HoustonHoustonTexas77089-

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNBaylor College of Medicine· Houston, TXUniversity of Texas Health Science Center at Houston· Houston, TX

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