Overview

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 October 2010
End date January 2014
Trial size 93 participants
Trial identifier NCT01151020, 10-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
zenith® tx2® low profile taa endovascular graft TEVAR
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair

Primary Outcomes

Measure
Number of patients free from major adverse events
time frame: 30 days

Secondary Outcomes

Measure
Device success
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

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 January 2015.
Information provided to ClinicalTrials.gov by Cook.