Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic - Full Text View

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:

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

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 [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ] [ Designated as safety issue: No ]
Total time required for surgical device implantation (recorded in minutes).
Operative Blood Loss [ Time Frame: Initial Device Implant Procedure During Index Hospitalization ] [ Designated as safety issue: Yes ]
Convalescence Stay in an Intensive Care Unit [ Time Frame: During the Index Hospitalization ] [ Designated as safety issue: Yes ]
Total Length of Hospital Stay [ Time Frame: Total Duration of the Index Hospitalization ] [ Designated as safety issue: No ]
Time to Return to Normal Daily Activities [ Time Frame: Average time of one month ] [ Designated as safety issue: No ]
This is the self reported time 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:

Presence of DTA aneurysm deemed to warrant surgical repair

>
- Fusiform (≥50 mm), or >
- Saccular (no diameter criteria)
Subject is > 21 years of age

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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
All proximal and distal landing zone inner diameters are between 16-42 mm

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• Diameter assessed by flow lumen and thrombus, if present; calcium excluded

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Life expectancy > 2 years

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Able to tolerate thoracotomy >
Male or infertile female >
Able to comply with protocol requirements including following-up

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Signed informed consent

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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)

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Mycotic aneurysm

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Hemodynamically unstable aneurysm rupture

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Aortic dissection

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Planned coverage of left carotid or celiac arteries with the CTAG Device

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Planned concomitant surgical procedure (other than left subclavian transposition and wireless sac pressure monitoring), or major surgery within 30 days of treatment date

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Known degenerative connective tissue disease, e.g. Marfan or Ehler-Danlos Syndrome

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Known history of drug abuse

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ASA risk classification = V (moribund patient not expected to live 24 hours with or without operation)

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NYHA class IV

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Participating in another investigational device or drug study within 1 year of treatment

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Subject has known sensitivities or allergies to the device materials

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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:	February 12, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013