Clinical trial NCT00874250: Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
Official title: An Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for the Primary Treatment of Aneurysm of the Descending Thoracic Aortic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysm
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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\>

Primary outcomes:
measure: The Number of Subjects Free From a Major Device Event Through 1 Month Post-treatment
timeFrame: Treatment through 1 month post treatment
Secondary outcomes:
measure: The Number of Subjects Experiencing a Serious Adverse Event Through One Month Post Treatment.
timeFrame: Treatment through 1 month post procedure
measure: Procedure Time (Minutes)
timeFrame: Initial Device Implant Procedure During Index Hospitalization
measure: Operative Blood Loss (mL)
timeFrame: Initial Device Implant Procedure During Index Hospitalization
measure: Days of Convalescence Stay in an Intensive Care Unit
timeFrame: During the Index Hospitalization
measure: Total Length of Hospital Stay (Days)
timeFrame: Total Duration of the Index Hospitalization
measure: Time in Days to Return to Normal Daily Activities
timeFrame: Average time within one month window
measure: Procedural Survival
timeFrame: Initial Device Implant Procedure During Index Hospitalization
measure: Intensive Care Unit (ICU) Stay
timeFrame: Initial Device Implant Index Hospitalization
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Medical Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: William D Jordan, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.