Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic

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

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

Study Overview

• Status: Completed
• Conditions: Aneurysm
• Intervention / Treatment: Device: GORE CTAG Device

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: GORE Conformable TAG® Thoracic Endoprosthesis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: William D Jordan, Dr., University of Alabama at Birmingham

Publications and helpful links

General 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.
• Jordan WD, Desai N, Letter AJ, Matsumura JS. Long-term outcomes of the conformable TAG thoracic endoprosthesis in a prospective multicenter trial. J Vasc Surg. 2021 Nov;74(5):1491-1498. doi: 10.1016/j.jvs.2021.04.063. Epub 2021 May 20.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: March 31, 2009
• First Submitted That Met QC Criteria: March 31, 2009
• First Posted (Estimate): April 2, 2009

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm
• Other Study ID Numbers: TAG 08-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO