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Completed

NCT Number: NCT00874250

Thoracic Endoprosthesis for 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

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Key information

Conditions

Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

>

  • 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>

Treatment and study plan

GORE CTAG Device

Device

Endovascular aortic stent-graft

Other names: GORE Conformable TAG® Thoracic Endoprosthesis

Primary outcomes

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

    Time frame: Treatment through 1 month post treatment

Secondary outcomes

  1. The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.

    Time frame: Treatment through 1 month post procedure

  2. Procedure Time (Minutes)

    Time frame: Initial Device Implant Procedure During Index Hospitalization

    Total time in minutes required for surgical device implantation.

  3. Operative Blood Loss (mL)

    Time frame: Initial Device Implant Procedure During Index Hospitalization

    Blood loss in mL during initial device implantation procedure

  4. Days of Convalescence Stay in an Intensive Care Unit

    Time frame: During the Index Hospitalization

    Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation

  5. Total Length of Hospital Stay (Days)

    Time frame: Total Duration of the Index Hospitalization

    Total days of hospital stay during the initial hospitalization for implantation of device

  6. Time in Days to Return to Normal Daily Activities

    Time frame: Average time within one month window

    This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.

  7. Procedural Survival

    Time frame: Initial Device Implant Procedure During Index Hospitalization

    Subjects who survived the index procedure

  8. Intensive Care Unit (ICU) Stay

    Time frame: Initial Device Implant Index Hospitalization

    Subjects admitted to ICU during index hospitalization

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic

Important dates

Study start
2009
Primary completion
2011
Study completion
2017
First posted
Apr 2, 2009
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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