Overview

This trial is active, not recruiting.

Condition aneurysm
Treatment gore ctag device
Sponsor W.L.Gore & Associates
Start date June 2009
End date January 2011
Trial size 51 participants
Trial identifier NCT00874250, TAG 08-03

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
gore ctag device GORE Conformable TAG® Thoracic Endoprosthesis
Endovascular aortic stent-graft

Primary Outcomes

Measure
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

Measure
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
Operative Blood Loss (mL)
time frame: Initial Device Implant Procedure During Index Hospitalization
Days of Convalescence Stay in an Intensive Care Unit
time frame: During the Index Hospitalization
Total Length of Hospital Stay (Days)
time frame: Total Duration of the Index Hospitalization
Time in Days to Return to Normal Daily Activities
time frame: Average time of one month

Eligibility Criteria

Male or female participants at least 21 years old.

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 >

Additional Information

Official title An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
Principal investigator William D Jordan, Dr.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.