Zenith(RegisteredTM) TX2(RegisteredTM) Low Profile Endovascular Graft for Blunt Thoracic Aortic Injury Clinical Study

Study ID
STU 112012-015

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
David Timaran Montenegro
214-645-0545
david.timaran@utsouthwestern.edu

Principal Investigator
Carlos Timaran

Summary

This study will be conducted as a prospective, nonrandomized, noncomparative, single-arm study enrolling a total of 50 patients at up to 30 global centers. The purpose of this study is to assess the safety and effectiveness of the Zenith[RegisteredTM] TX2[RegisteredTM] Low Profile endovascular Graft in the treatment of patients with blunt thoracic aortic injury (BTai).

The objectives of the study are to evaluate the safety and effectiveness of the Zenith[RegisteredTM] TX2[RegisteredTM] Low Profile endovascular Graft for the treatment of patients with BTai. The primary safety endpoint will be all-cause and aortic-injury-related mortality at 30 days. The primary effectiveness endpoint will be device success at 30 days.

Participant Eligibility

1) Blunt thoracic aortic injury of the descending thoracic aorta
2) Suitable for treatment with the Zenith(RegisteredTM) TX2(RegisteredTM) Low Profile Endovascular Graft and
16 Fr, 18 Fr, or 20 Fr Z-Trak Plus(RegisteredTM) Introduction System
3) Treatment with the Zenith(RegisteredTM) TX2(RegisteredTM) Low Profile Endovascular Graft can be performed
within 14 days of the blunt thoracic aortic injury
4) Age >= 16 years
5) Proximal fixation site length measuring >= 20 mm between the left common carotid
artery and most proximal extent of the injury site (covering left subclavian artery is
acceptable)
6) Distal fixation site length measuring >= 20 mm between the distal-most aspect of
aortic injury and most distal extent of graft
7) No previous placement of a thoracic endovascular graft
8) No prior open surgical repair involving the descending thoracic aorta including
suprarenal aorta and/or arch
9) Proximal neck diameter, measured outer-wall to outer-wall on a sectional image or
multiplanar reconstruction (CT), >= 15 mm and <= 42 mm
10) Distal neck diameter, measured outer-wall to outer-wall on a sectional image or
multiplanar reconstruction (CT), >= 15 mm and <= 42 mm
11) Ability to preserve the left common carotid artery and celiac artery
12)Willing and able to comply with the follow-up schedule
13) Informed consent given by the patient or a legally authorized representative [Note:
For pediatric patients, in addition to obtaining permission from their parents or
guardians, assent from the patients may need to be obtained based on IRB
requirements. See Section 6.2 for further information.