TRANSFIX Zenith® Transection Clinical Study

Cook Group

Status: Completed

Conditions: Thoracic Aorta; Thoracic Injuries; Blunt Injuries

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01688050

11-004

Details and patient eligibility

About

The TRANSFIX study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® TX2® Low Profile Endovascular Graft for treatment of Blunt Thoracic Aortic Injury.

Enrollment: 50 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vessels suitable for endovascular access and stent graft placement
• Blunt thoracic aortic injury of the descending thoracic aorta
• At least 16 years of age
• Informed consent given by patient or legally authorized representative

Exclusion criteria

• Clinical considerations that would compromise patient safety or study outcomes
• Unsuitable arterial anatomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Endovascular Repair

Experimental group

Treatment:

Device: Zenith® TX2® Low Profile Endovascular Graft