Clinical trial NCT02471781: Zenith® TX2® Low Profile TAA Endovascular Graft
Official title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Aortic Aneurysm
Penetrating Ulcer
Vascular Disease
Keywords: Aortic Aneurysm
Aneurysm
Vascular Prosthesis
Vascular Disease
Blood Vessel Prosthesis Implantation
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-06-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.


Eligibility criteria: Inclusion Criteria:

* Meets one of the following

  * Descending thoracic aneurysm with diameter ≥ 5.0 cm
  * Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
  * Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

* Life expectancy less than 2 years
* Pregnant of breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Less than 30 days beyond primary endpoint for other investigative drug or device study
* Receiving home oxygen
* Myocardial infarction within the last 3 months
* Stroke within the last 3 months
* Diagnosed or suspected congenital degenerative collagen disease
* Systemic infection
* Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
* Allergy to polyester, polypropylene, nitinol, or gold
* Previous placement of a thoracic endovascular graft
* Prior open repair involving the descending thoracic aorta

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Methodist Hospital of Indiana
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Dialysis Access Center
name: Karl Illig, MD
role: PRINCIPAL_INVESTIGATOR
References: