Zenith® TX2® Low Profile TAA Endovascular Graft

Cook Group

Status

Conditions: Penetrating Ulcer; Vascular Disease; Aortic Aneurysm

Treatments: Device: Zenith TX2 Low Profile TAA Endovascular Graft

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02471781

10-001 CA

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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