Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Cook Group Incorporated15 sites in 1 countryJune 15, 2015

ConditionsAortic Aneurysm Penetrating Ulcer Vascular Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Aneurysm
Sponsor: Cook Group Incorporated
Locations: 15
Status: Approved For Marketing
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 15, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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