Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

NAEnrolling by invitationINTERVENTIONAL
Enrollment

625

Participants

Timeline

Start Date

December 1, 2014

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Aortic Aneurysm, AbdominalThoracic Aneurysm
Interventions
DEVICE

Fenestrated CMD

"The CMD that will be used in this IDE is structurally the same as the commercially available Zenith Fenestrated AAA Endovascular Graft.~In general, the Zenith® Fenestrated AAA Endovascular Graft is a modular system constructed of full- thickness woven polyster fabric sewn to self-expanding stainless steel z-stents with braided polyster and monofilament polypropylene sutures. In this study, fenestrated grafts with usually up to 4 fenestrations may be used.~Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms."

DEVICE

Type I - III TAAA

"Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms. Devices will be implanted in patients with type I-III thoracic abdominal aneurysms.~The branches in this study will be constructed as internal/external cuffs, axially oriented and caudally or cranially directed, as necessary . Branch position will be determined by the anatomic location of the target vessels using a consistent craniocaudal and circumferential cuff position."

DEVICE

Arch cohort

Arch branched devices may be designed using one of two configurations: (1) Zone 0 device with two inner antegrade branches for the innominate artery and the left common carotid artery with or without a retrograde left subclavian artery branch and (2) Zone 1-2 device with a single retrograde subclavian artery branch with double or triple wide scallop for the left common carotid artery. These devices are designed for a of proximal landing/fixation zone of at least 20 mm of healthy aortic segment or a previous graft.

Trial Locations (1)

75390-9157

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors
lead

University of Texas Southwestern Medical Center

OTHER