Clinical trial NCT01151020: TX2® Low Profile TAA Endovascular Graft
Official title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: 2010-06-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.


Eligibility criteria: Inclusion Criteria:

* 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:

* Less than 18 years of age
* Life expectancy less than 2 years
* Pregnant or breastfeeding or planning on becoming pregnant within 60 months
* Unwilling to comply with the follow-up schedule
* Inability or refusal to give informed consent
* Less than 30 days beyond primary endpoint for other investigative drug or device study

Primary outcomes:
measure: Patients With Major Adverse Events (MAE)
timeFrame: 30 days
measure: Patients With Device Failures
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
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
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
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: New York University Hospital
state: New York
city: New York
country: United States
facility: 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: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
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
city: Memphis
country: United States
facility: Tennessee Baptist Memorial Hospital
state: Tennessee
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Hannover
country: Germany
facility: Hannover Medical School
city: Munster
country: Germany
facility: St. Franziskus Hospital
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Sud
city: Regensburg
country: Germany
facility: Uniklinik Regensburg
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Milan
country: Italy
facility: Hospital San Raffaele
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Tokyo
country: Japan
facility: Jikei University School of Medicine
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Malmö
country: Sweden
facility: Malmö University Hospital
city: London
country: United Kingdom
facility: St.George's Hospital
Study officials:
affiliation: University of South Florida
name: Karl Illig, MD
role: PRINCIPAL_INVESTIGATOR
References: