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
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 April 22, 2014