South American Thoracic Stent-Graft Study | NCT01082172

Studies
South American Thoracic Stent-Graft Study

NCT01082172

Sponsor

TriVascular, Inc.

Status

Completed

Last Update Posted

Mar 8, 2021Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Thoracic Aortic Aneurysm

Interventions

Implant Thoracic Stent Graft

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2011Actual

First Submitted Date

Mar 4, 2010

First Submission Date that Met QC Criteria

Mar 5, 2010

First Posted Date

Mar 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2021

Last Update Posted Date

Mar 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thoracic Stent Graft	Experimental	Thoracic Stent Graft implanted device	Device: Implant Thoracic Stent Graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implant Thoracic Stent Graft	Device	Endovascular implant of Thoracic Aortic Aneurysm Stent Graft	Thoracic Stent Graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of device-related serious adverse events within 30-days of endovascular procedure		30-Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pontificia Universidad Caolica de Chile		Santiago			Chile

Condition Browse Module

MeSH Terms

ID	Term
D017545	Aortic Aneurysm, Thoracic
D000783	Aneurysm

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided