NCT01082172

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

6 months

First QC Date

March 4, 2010

Last Update Submit

March 4, 2021

Conditions

Thoracic Aortic Aneurysm

Keywords

thoracicaorticaneurysmTAA

Outcome Measures

Primary Outcomes (1)

  • Absence of device-related serious adverse events within 30-days of endovascular procedure

    30-Days

Study Arms (1)

Thoracic Stent Graft

EXPERIMENTAL

Thoracic Stent Graft implanted device

Device: Implant Thoracic Stent Graft

Interventions

Implant Thoracic Stent GraftDEVICE

Endovascular implant of Thoracic Aortic Aneurysm Stent Graft

Thoracic Stent Graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Caolica de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAneurysm

Condition Hierarchy (Ancestors)

Aortic AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2010

First Posted

March 8, 2010

Study Start

November 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2011

Last Updated

March 8, 2021

Record last verified: 2021-03

Locations

CL(1)