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

Summary

The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop

Conditions

• Aortic Aneurysm, Abdominal
• Thoracic 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 polyester fabric sewn to self-expanding stainless steel z-stents with braided polyester and monofilament polypropylene sutures. In this study, fenestrated grafts with up to 4 fenestrations may be used. Device implantation will be performed using standardized endovascular techniques used in the treatment of abdominal aortic aneurysms.

DEVICE

Type I - III TAAA

Device implantation will be performed using standardized endovascular 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 either caudally or cranially directed, as necessary. The 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.

Sponsors & Collaborators

• Cook Research Incorporated

  collaborator INDUSTRY

• Carlos Timaran

  lead OTHER

Principal Investigators

• Carlos H. Timaran, MD · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-01

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Device

Yes

Countries

• United States

Study Locations