Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00874250
First received: March 31, 2009
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Aneurysm
Device: GORE CTAG Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment [ Time Frame: Treatment through 1 month post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. [ Time Frame: Treatment through 1 month post procedure ] [ Designated as safety issue: Yes ]
  • Procedure Time (Minutes) [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ] [ Designated as safety issue: No ]
    Total time in minutes required for surgical device implantation.

  • Operative Blood Loss (mL) [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ] [ Designated as safety issue: Yes ]
    Blood loss in mL during initial device implantation procedure

  • Days of Convalescence Stay in an Intensive Care Unit [ Time Frame: During the Index Hospitalization ] [ Designated as safety issue: Yes ]
    Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation

  • Total Length of Hospital Stay (Days) [ Time Frame: Total Duration of the Index Hospitalization ] [ Designated as safety issue: No ]
    Total days of hospital stay during the initial hospitalization for implantation of device

  • Time in Days to Return to Normal Daily Activities [ Time Frame: Average time of one month ] [ Designated as safety issue: No ]
    This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.


Enrollment: 51
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GORE CTAG Device
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.
Device: GORE CTAG Device
Endovascular aortic stent-graft
Other Name: GORE Conformable TAG® Thoracic Endoprosthesis

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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 >
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874250

Locations
United States, Alabama
University of Alabama Medical Center
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: William D Jordan, Dr. University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00874250     History of Changes
Other Study ID Numbers: TAG 08-03
Study First Received: March 31, 2009
Results First Received: September 22, 2011
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014