Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft

NARecruitingINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

March 31, 2025

Study Completion Date

May 31, 2030

Conditions
Complex Abdominal Aortic AneurysmThoracoabdominal Aortic AneurysmAortic Arch AneurysmAortic Arch Dissection
Interventions
DEVICE

Thoracoabdominal Aortic Aneurysm Arm

"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). 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."

DEVICE

Aortic Arch Aneurysm Arm

The 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.

Trial Locations (2)

55905

ACTIVE_NOT_RECRUITING

Mayo Clinic, Rochester

77030

RECRUITING

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
collaborator

William Cook Australia

INDUSTRY

lead

Gustavo Oderich

OTHER