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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Carlos Timaran
Study ID
NCT02266719
Status
Enrolling By Invitation

Conditions

  • Aortic Aneurysm, Abdominal
  • Thoracic Aneurysm

Eligibility Criteria

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

Interventions

  • Fenestrated CMD — DEVICE
    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.
  • Type I - III TAAA — DEVICE
    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.
  • Arch cohort — DEVICE
    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.

Study Details

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

Key Dates

Start date
Dec 1, 2014
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
750 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fenestrated CMD cohort
    Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.
  • Experimental: Type I - III TAAA cohort
    Patients enrolled in this arm will be implanted with the custom-made/ off-the-shelf branched devices. The device is aimed to treat type I-III TAAAs.
  • Experimental: Arch cohort
    Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.

Primary Outcome Measure

Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices. [ Time Frame: 30 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30322-
Emory HospitalAtlantaGeorgia30322-
Emory UniversityAtlantaGeorgia30322-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Atlanta, GA

By research site
Emory Clinic· Atlanta, GAEmory Hospital· Atlanta, GAEmory University· Atlanta, GAUniversity of Texas Southwestern Medical Center· Dallas, TX

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