South American Thoracic Stent-Graft Study

TriVascular

Status: Completed

Conditions: Thoracic Aortic Aneurysm

Treatments: Device: Implant Thoracic Stent Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082172

771-0001 TAA Trial

Details and patient eligibility

About

A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:

  • Adequate iliac/femoral access compatible with the required delivery systems,
  • Non-aneurysmal aortic segments proximal and distal to the aneurysm.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Thoracic Stent Graft

Experimental group

Description:

Thoracic Stent Graft implanted device

Treatment:

Device: Implant Thoracic Stent Graft