Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00874250
• Other study ID #: TAG 08-03
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2009
• Last updated: May 24, 2016
• Start date: June 2009
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: December 2016
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

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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

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5. Hemodynamically unstable aneurysm rupture

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6. Aortic dissection

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

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

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10. Known history of drug abuse

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

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12. NYHA class IV

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

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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 >

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm

Intervention

Device:
• GORE CTAG Device
Endovascular aortic stent-graft

Locations

Country	Name	City	State
United States	University of Alabama Medical Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment		Treatment through 1 month post treatment	Yes
Secondary	The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.		Treatment through 1 month post procedure	Yes
Secondary	Procedure Time (Minutes)	Total time in minutes required for surgical device implantation.	Initial Device Implant Procedure During Index Hospitalization	No
Secondary	Operative Blood Loss (mL)	Blood loss in mL during initial device implantation procedure	Initial Device Implant Procedure During Index Hospitalization	Yes
Secondary	Days of Convalescence Stay in an Intensive Care Unit	Convalescence stay (days) in an Intensive Care Unit during the initial hospitalization for the device implantation	During the Index Hospitalization	Yes
Secondary	Total Length of Hospital Stay (Days)	Total days of hospital stay during the initial hospitalization for implantation of device	Total Duration of the Index Hospitalization	No
Secondary	Time in Days to Return to Normal Daily Activities	This is the self reported time (in days) that the subject returned to pre-operative activities and is not a time to event analysis.	Average time of one month	No