TX2® Low Profile TAA Endovascular Graft (TX2® LP)

Cook Group

Status: Completed

Conditions: Penetrating Ulcer; Vascular Disease; Aortic Aneurysm

Treatments: Device: Zenith® TX2® Low Profile TAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01151020

10-001

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

Arm 1

Experimental group

Description:

Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Treatment:

Device: Zenith® TX2® Low Profile TAA Endovascular Graft