NCT00917852

Brief Summary

TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

26 active sites

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

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2012

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

August 25, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

June 8, 2009

Results QC Date

April 4, 2012

Last Update Submit

July 26, 2017

Conditions

Thoracic Injuries

Keywords

aortatraumatransection

Outcome Measures

Primary Outcomes (2)

  • All Cause Mortality

    30 days post-treatment

  • Major Device Events

    Major device events requiring reintervention through 1 month study window. Possible device events include but are not limited to endoleak, migration, wire fracture, compression, erosion, extrusion, aortic dilatation, endograft infection, and aortic rupture.

    1 month post-treatment

Study Arms (1)

GORE Conformable TAG® Thoracic Endoprosthesis

EXPERIMENTAL
Device: Gore Conformable TAG Thoracic Endoprosthesis

Interventions

Gore Conformable TAG Thoracic EndoprosthesisDEVICE

Endovascular stent graft

GORE Conformable TAG® Thoracic Endoprosthesis

Eligibility Criteria

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

You may qualify if:

  • Traumatic transection of the DTA that requires repair, determined by the treating physician
  • Traumatic aortic transection location between, but does not include, the left subclavian artery and celiac artery
  • Endovascular repair with the GORE Conformable TAG® Device performed less than or = to 14 days after aortic injury
  • Age greater than or equal to 18 years
  • Proximal and distal landing zone length greater than or equal to 2.0 cm. Landing zones must be in native aorta. Landing zone may include left subclavian artery, if necessary
  • All proximal and distal landing zone inner diameters are between 16-42 mm. Diameter assessed by flow lumen and thrombus, if present; calcium excluded
  • Subject capable of complying with study protocol requirements, including follow-up
  • Informed Consent Form signed by subject or legal representative

You may not qualify if:

  • Differing proximal and distal neck diameters (aortic taper) outside the intended aortic diameter requirements (sizing guide) for a single endoprosthesis diameter and the inability to use devices of different diameters (in adherence to the sizing guide) to compensate for the taper
  • Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access
  • Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  • Infected aorta
  • Subject has a systemic infection and may be at increased risk of endovascular graft infection
  • Planned coverage of left carotid or celiac arteries with the CTAG Device
  • Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  • Treatment in another drug or medical device study within 1 year of study enrollment
  • Known history of drug abuse
  • Pregnant female
  • Moribund patient not expected to live 24 hours with or without operation, determined by the treating physician
  • Injury Severity Score of 75
  • Subject has known sensitivities or allergies to the device materials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Stanford, California, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Lebanon, New Hampshire, United States

Location

Unknown Facility

Lake Success, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Charlotte, North Carolina, United States

Location

Unknown Facility

Greenville, North Carolina, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Charleston, South Carolina, United States

Location

Unknown Facility

Greenville, South Carolina, United States

Location

Unknown Facility

Knoxville, Tennessee, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Temple, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Related Publications (1)

  • Panthofer AM, Olson SL, Harris DG, Matsumura JS. Derivation and validation of thoracic sarcopenia assessment in patients undergoing thoracic endovascular aortic repair. J Vasc Surg. 2019 May;69(5):1379-1386. doi: 10.1016/j.jvs.2018.08.180. Epub 2018 Dec 28.

    PMID: 30598352DERIVED

MeSH Terms

Conditions

Thoracic InjuriesWounds and Injuries

Results Point of Contact

Title
Abe Letter
Organization
W.L. Gore & Associates
aletter@wlgore.com
928-864-3113

Study Officials

  • Mark Farber, M.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

June 8, 2009

First Posted

June 10, 2009

Study Start

November 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 28, 2017

Last Updated

August 25, 2017

Results First Posted

May 1, 2012

Record last verified: 2017-07

Locations

US(26)