N/A
N=110
TX2® Low Profile TAA Endovascular Graft
Aortic Aneurysm · Penetrating Ulcer · Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01151020 ↗Enrolled (actual)
110
Serious AEs
78.2%
Results posted
Feb 2016
Primary outcome: Primary: Patients With Major Adverse Events (MAE) — 2; 3 participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zenith® TX2® Low Profile TAA Endovascular Graft (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Research Incorporated
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Major Adverse Events (MAE) |
2; 3 | < 0.001 sig |
| PRIMARY Patients With Device Failures |
2; 2; 1; 3 | < 0.001 sig |
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
Data sourced from ClinicalTrials.gov (NCT01151020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.