This trial is active, not recruiting.

Conditions aortic aneurysm, penetrating ulcer, vascular disease
Treatment zenith tx2 low profile taa endovascular graft
Sponsor Cook
Start date April 2013
End date January 2016
Trial size 18 participants
Trial identifier NCT02471781, 10-001 CA, NCT02319551


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Zenith TX2 Low Profile TAA Endovascular Graft
zenith tx2 low profile taa endovascular graft Zenith Alpha Thoracic™ Endovascular Graft
Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.

Primary Outcomes

Rate of major adverse events
time frame: 30 days

Secondary Outcomes

Rate of device success
time frame: 30 days
Rate of device success
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Principal investigator Karl Illig, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Cook.