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Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Primary Purpose

Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE CTAG Device
Sponsored by
W.L.Gore & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm

Eligibility Criteria

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

Inclusion Criteria:>

1. Presence of DTA aneurysm deemed to warrant surgical repair >

  • Fusiform (≥50 mm), or >
  • Saccular (no diameter criteria)> 2. Subject is > 21 years of age> 3. Proximal and distal landing zone length ≥ 2.0 cm >
  • Landing zones must be in native aorta>
  • Landing zone may include left subclavian artery, if necessary> 4. All proximal and distal landing zone inner diameters are between 16-42 mm>
  • Diameter assessed by flow lumen and thrombus, if present; calcium excluded> 5. Life expectancy > 2 years> 6. Able to tolerate thoracotomy > 7. Male or infertile female> 8. Able to comply with protocol requirements including following-up> 9. Signed informed consent>

Exclusion Criteria:>

  1. 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>
  2. Tortuous or stenotic iliac and/or femoral arteries and inability to use a conduit for vascular access>
  3. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)>
  4. Mycotic aneurysm>
  5. Hemodynamically unstable aneurysm rupture>
  6. Aortic dissection>
  7. Planned coverage of left carotid or celiac arteries with the CTAG Device>
  8. Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date>
  9. Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome>
  10. Known history of drug abuse>
  11. ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)>
  12. NYHA class IV >
  13. Participating in another investigational device or drug study within 1 year of treatment>
  14. Subject has known sensitivities or allergies to the device materials>
  15. Subject has a systemic infection and may be at increased risk of endovascular graft infection>

Sites / Locations

  • University of Alabama Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GORE CTAG Device

Arm Description

The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.

Outcomes

Primary Outcome Measures

The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment

Secondary Outcome Measures

The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Procedure Time (Minutes)
Total time in minutes required for surgical device implantation.
Operative Blood Loss (mL)
Blood loss in mL during initial device implantation procedure
Days of Convalescence Stay in an Intensive Care Unit
Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Total Length of Hospital Stay (Days)
Total days of hospital stay during the initial hospitalization for implantation of device
Time in Days to Return to Normal Daily Activities
This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Procedural Survival
Subjects who survived the index procedure
Intensive Care Unit (ICU) Stay
Subjects admitted to ICU during index hospitalization

Full Information

First Posted
March 31, 2009
Last Updated
July 26, 2017
Sponsor
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00874250
Brief Title
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Official Title
An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 6, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) > Primary Hypothesis: The proportion of subjects free from a major device event through 1 month post-treatment will not be significantly less than 0.95, which represents the proportion observed in previous clinical studies with the GORE TAG® Thoracic Endoprosthesis

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GORE CTAG Device
Arm Type
Experimental
Arm Description
The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
Intervention Type
Device
Intervention Name(s)
GORE CTAG Device
Other Intervention Name(s)
GORE Conformable TAG® Thoracic Endoprosthesis
Intervention Description
Endovascular aortic stent-graft
Primary Outcome Measure Information:
Title
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
Time Frame
Treatment through 1 month post treatment
Secondary Outcome Measure Information:
Title
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
Time Frame
Treatment through 1 month post procedure
Title
Procedure Time (Minutes)
Description
Total time in minutes required for surgical device implantation.
Time Frame
Initial Device Implant Procedure During Index Hospitalization
Title
Operative Blood Loss (mL)
Description
Blood loss in mL during initial device implantation procedure
Time Frame
Initial Device Implant Procedure During Index Hospitalization
Title
Days of Convalescence Stay in an Intensive Care Unit
Description
Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation
Time Frame
During the Index Hospitalization
Title
Total Length of Hospital Stay (Days)
Description
Total days of hospital stay during the initial hospitalization for implantation of device
Time Frame
Total Duration of the Index Hospitalization
Title
Time in Days to Return to Normal Daily Activities
Description
This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.
Time Frame
Average time within one month window
Title
Procedural Survival
Description
Subjects who survived the index procedure
Time Frame
Initial Device Implant Procedure During Index Hospitalization
Title
Intensive Care Unit (ICU) Stay
Description
Subjects admitted to ICU during index hospitalization
Time Frame
Initial Device Implant Index Hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:> 1. Presence of DTA aneurysm deemed to warrant surgical repair > Fusiform (≥50 mm), or > Saccular (no diameter criteria)> 2. Subject is > 21 years of age> 3. Proximal and distal landing zone length ≥ 2.0 cm > Landing zones must be in native aorta> Landing zone may include left subclavian artery, if necessary> 4. All proximal and distal landing zone inner diameters are between 16-42 mm> Diameter assessed by flow lumen and thrombus, if present; calcium excluded> 5. Life expectancy > 2 years> 6. Able to tolerate thoracotomy > 7. Male or infertile female> 8. Able to comply with protocol requirements including following-up> 9. Signed informed consent> Exclusion Criteria:> 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)> Mycotic aneurysm> Hemodynamically unstable aneurysm rupture> Aortic dissection> Planned coverage of left carotid or celiac arteries with the CTAG Device> Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date> Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome> Known history of drug abuse> ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)> NYHA class IV > Participating in another investigational device or drug study within 1 year of treatment> Subject has known sensitivities or allergies to the device materials> Subject has a systemic infection and may be at increased risk of endovascular graft infection>
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William D Jordan, Dr.
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34022380
Citation
Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.
Results Reference
derived
PubMed Identifier
30598352
Citation
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.
Results Reference
derived

Learn more about this trial

Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

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