NCT01082172CompletedNot Applicable
A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TriVascular, Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Absence of device-related serious adverse events within 30-days of endovascular procedure
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Thoracic Stent Graft
Experimental
Thoracic Stent Graft implanted device
Intervention: Implant Thoracic Stent Graft (Device)
Outcomes
Primary Outcomes
Absence of device-related serious adverse events within 30-days of endovascular procedure
Time Frame: 30-Days
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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