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

March 31, 2009
April 2, 2014
June 2009
January 2011   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00874250 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
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Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aneurysm
Device: GORE CTAG Device
Endovascular aortic stent-graft
Other Name: GORE Conformable TAG® Thoracic Endoprosthesis
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.
Intervention: Device: GORE CTAG Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
51
December 2015
January 2011   (final data collection date for primary outcome measure)

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 >
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00874250
TAG 08-03
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Principal Investigator: William D Jordan, Dr. University of Alabama at Birmingham
W.L.Gore & Associates
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP