Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

Not Applicable

Completed

• Conditions: Aneurysm
• Interventions: Device: GORE CTAG Device

• Registration Number: NCT00874250
• Lead Sponsor: W.L.Gore & Associates

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 available

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-02
• Study Start: 2009-06
• Primary Completion: 2011-01
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-11-08
• Results First Posted: 2011-12-13
• Study Completion: 2017-01-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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>

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GORE CTAG Device	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.

Primary Outcome Measures

Name	Time	Method
The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment	Treatment through 1 month post treatment

Secondary Outcome Measures

Name	Time	Method
The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.	Treatment through 1 month post procedure
Days of Convalescence Stay in an Intensive Care Unit	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)	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	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	Initial Device Implant Procedure During Index Hospitalization	Subjects who survived the index procedure
Intensive Care Unit (ICU) Stay	Initial Device Implant Index Hospitalization	Subjects admitted to ICU during index hospitalization
Procedure Time (Minutes)	Initial Device Implant Procedure During Index Hospitalization	Total time in minutes required for surgical device implantation.
Operative Blood Loss (mL)	Initial Device Implant Procedure During Index Hospitalization	Blood loss in mL during initial device implantation procedure

Trial Locations

Locations (1)

University of Alabama Medical Center; 🇺🇸 Birmingham, Alabama, United States