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GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

Primary Purpose

Aortic Aneurysm, Thoracic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GORE TAG® Thoracic Endoprosthesis
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Thoracic

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

    • Fusiform (≥50 mm), or
    • Saccular (no diameter criteria)

  2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

    • Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications

  3. Proximal and distal landing zone length greater than 2.0 cm

    • Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed
  4. Life expectancy > 2 years

  5. Subject is open surgical candidate defined as:

    • Able to tolerate thoracotomy
    • American Society of Anesthesiologists class I-IV (class V excluded)
    • New York Heart Association class I-III or not applicable (class IV excluded)
  6. Male or infertile female
  7. Age greater than 21 years
  8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria:

  1. Mycotic aneurysm
  2. Hemodynamically unstable aneurysm rupture
  3. Aortic dissection
  4. Planned occlusion of left carotid or celiac arteries
  5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date
  6. Myocardial infarction or stroke within 6 weeks of treatment
  7. Pre-treatment creatinine > 2.0 mg/dL
  8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  9. Participation in another drug or device study within 1 year of treatment
  10. History of drug abuse within 6 months of treatment

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GORE TAG® Thoracic Endoprosthesis

Arm Description

Gore 45mm TAG Thoracic Endograft Implantation

Outcomes

Primary Outcome Measures

Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).

Secondary Outcome Measures

Full Information

First Posted
December 20, 2007
Last Updated
March 4, 2015
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00608829
Brief Title
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
Official Title
Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GORE TAG® Thoracic Endoprosthesis
Arm Type
Experimental
Arm Description
Gore 45mm TAG Thoracic Endograft Implantation
Intervention Type
Device
Intervention Name(s)
GORE TAG® Thoracic Endoprosthesis
Other Intervention Name(s)
GORE TAG® Thoracic Endoprosthesis - 45 mm
Intervention Description
Implant
Primary Outcome Measure Information:
Title
Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment
Description
Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair Fusiform (≥50 mm), or Saccular (no diameter criteria) All proximal and/or all distal landing zone inner diameters between 37-42 mm Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications Proximal and distal landing zone length greater than 2.0 cm Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed Life expectancy > 2 years Subject is open surgical candidate defined as: Able to tolerate thoracotomy American Society of Anesthesiologists class I-IV (class V excluded) New York Heart Association class I-III or not applicable (class IV excluded) Male or infertile female Age greater than 21 years Able to comply with study protocol requirements, including follow-up Exclusion Criteria: Mycotic aneurysm Hemodynamically unstable aneurysm rupture Aortic dissection Planned occlusion of left carotid or celiac arteries Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date Myocardial infarction or stroke within 6 weeks of treatment Pre-treatment creatinine > 2.0 mg/dL Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome Participation in another drug or device study within 1 year of treatment History of drug abuse within 6 months of treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Makaroun, MD
Organizational Affiliation
University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

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