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NCT02471781 Clinical Trial

Zenith® TX2® Low Profile TAA Endovascular Graft

Aortic Aneurysm Clinical Trial

Official title:
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT02471781
Other study ID # 10-001 CA
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date January 2020
Source Cook Group Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Other known NCT identifiers
  • NCT02319551

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zenith TX2 Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.

Locations
Country Name City State
United States University of Michigan Health System Ann Arbor Michigan
United States Emory University Atlanta Georgia
United States Cooper University Hospital Camden New Jersey
United States University of North Carolina Chapel Hill North Carolina
United States Ohio State University Columbus Ohio
United States Duke University Medical Center Durham North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Indiana Heart Hospital Indianapolis Indiana
United States Methodist Hospital of Indiana Indianapolis Indiana
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States The Mount Sinai Hospital New York New York
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Barnes-Jewish Hospital Saint Louis Missouri
United States University of South Florida Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Cook Group Incorporated

Country where clinical trial is conducted

United States, 

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