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Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874250
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : December 13, 2011
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE March 31, 2009
First Posted Date  ICMJE April 2, 2009
Results First Submitted Date  ICMJE September 22, 2011
Results First Posted Date  ICMJE December 13, 2011
Last Update Posted Date August 25, 2017
Study Start Date  ICMJE June 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2011)
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment [ Time Frame: Treatment through 1 month post treatment ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment. [ Time Frame: Treatment through 1 month post procedure ]
  • Procedure Time (Minutes) [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]
    Total time in minutes required for surgical device implantation.
  • Operative Blood Loss (mL) [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]
    Blood loss in mL during initial device implantation procedure
  • 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
  • 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
  • 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.
  • Procedural Survival [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ]
    Subjects who survived the index procedure
  • Intensive Care Unit (ICU) Stay [ Time Frame: Initial Device Implant Index Hospitalization ]
    Subjects admitted to ICU during index hospitalization
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Official Title  ICMJE An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aneurysm
Intervention  ICMJE Device: GORE CTAG Device
Endovascular aortic stent-graft
Other Name: GORE Conformable TAG® Thoracic Endoprosthesis
Study Arms  ICMJE 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2011)
51
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 6, 2017
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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>
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00874250
Other Study ID Numbers  ICMJE TAG 08-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William D Jordan, Dr. University of Alabama at Birmingham
PRS Account W.L.Gore & Associates
Verification Date July 2017

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