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Clinical Trials/NCT01082172
NCT01082172CompletedNot Applicable

A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System

TriVascular, Inc.1 site in 1 country2 target enrollmentStarted: November 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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