GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta

Aortic Aneurysm, Thoracic Clinical Trial

Official title:

Evaluation of the GORE TAG® Thoracic Endoprosthesis - 45 mm for the Primary Treatment of Aneurysms of the Descending Thoracic Aorta

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00608829
• Other study ID #: TAG 06-02
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2007
• Last updated: March 4, 2015
• Start date: February 2007
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• 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

The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 2014
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

• Fusiform (=50 mm), or

• Saccular (no diameter criteria)

2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

• Diameter taper between proximal and distal landing zones and the ability to use devices of different diameters to compensate for the taper must be within device sizing guide specifications

3. Proximal and distal landing zone length greater than 2.0 cm

• Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily thrombosed

4. Life expectancy > 2 years

5. Subject is open surgical candidate defined as:

• Able to tolerate thoracotomy

• American Society of Anesthesiologists class I-IV (class V excluded)

• New York Heart Association class I-III or not applicable (class IV excluded)

6. Male or infertile female

7. Age greater than 21 years

8. Able to comply with study protocol requirements, including follow-up

Exclusion Criteria:

1. Mycotic aneurysm

2. Hemodynamically unstable aneurysm rupture

3. Aortic dissection

4. Planned occlusion of left carotid or celiac arteries

5. Planned concomitant surgical procedure (other than left subclavian transposition), or major surgery within 30 days of treatment date

6. Myocardial infarction or stroke within 6 weeks of treatment

7. Pre-treatment creatinine > 2.0 mg/dL

8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

9. Participation in another drug or device study within 1 year of treatment

10. History of drug abuse within 6 months of treatment

Study Design

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Intervention

Device:
• GORE TAG® Thoracic Endoprosthesis
Implant

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

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	Freedom From Major Adverse Events and Major Device Events Through 1 Year Post-treatment	Major Adverse Event: a) requires therapy and short hospitalization (24 - 48 hours), b) requires major therapy, unplanned increase in level of care, prolonged hospitalization (>48 hours), c) permanent adverse sequelae, or d) death. (Sacks et. al.; JVIR, 1997; 8:137-149).	one year	Yes