Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2) (SSB 11-02)

• ClinicalTrials.gov Identifier: NCT02777593
• Recruitment Status: Recruiting
• First Posted: May 19, 2016
• Last Update Posted: March 2, 2020
• Sponsor: W.L.Gore & Associates
• Information provided by (Responsible Party): W.L.Gore & Associates

Tracking Information

• First Submitted Date: May 12, 2016
• First Posted Date: May 19, 2016
• Last Update Posted Date: March 2, 2020
• Study Start Date: August 2016
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 16, 2016)

Composite of technical success and adverse events for Zone 2 Subjects (Aneurysm Cohort) [ Time Frame: one year ]

Composite of the following events through 12 months: device technical success and absence of the following Core Lab and adverse events: aortic rupture, lesion related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis, additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the delivery system.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 2)
• Official Title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
• Brief Summary: The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Aortic Aneurysm, Thoracic
• Aorta; Lesion

Intervention

Device: GORE® TAG® Thoracic Branch Endoprosthesis

Endovascular repair with the TBE Device

Study Arms

• Zone 2 Aortic aneurysm
  Zone 2 Aortic Aneurysm
  Intervention: Device: GORE® TAG® Thoracic Branch Endoprosthesis
• Zone 2 Non-aneurysm aortic lesions
  Includes dissection, traumatic transection and other isolated lesion types
  Intervention: Device: GORE® TAG® Thoracic Branch Endoprosthesis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 24, 2019): 315
• Original Estimated Enrollment (submitted: May 16, 2016): 285
• Estimated Study Completion Date: November 2023
• Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
2. Age ≥18 years at time of informed consent signature
3. Subject is capable of complying with protocol requirements, including follow-up
4. Informed Consent Form (ICF) is signed by Subject or legal representative
5. Must have appropriate proximal aortic landing zone.
6. Must have appropriate target branch vessel landing zone
7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.

Exclusion Criteria:

1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
2. Previous endovascular repair of the ascending aorta
3. Previous endovascular repair of the DTA with a non-Gore device
4. Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
5. Infected aorta
6. Life expectancy <2 years
7. Myocardial infarction within 6 weeks prior to treatment
8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
9. Patient has a systemic infection and may be at increased risk of endovascular graft infection
10. Pregnant female at time of informed consent signature
11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
12. Participation in another drug or medical device study within one year of study enrollment
13. Known history of drug abuse within one year of treatment
14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
16. Planned coverage of celiac artery
17. Patient has known sensitivities or allergies to the device materials
18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
21. Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
22. Mycotic aneurysm
23. Persistent refractory shock (systolic blood pressure <90 mm Hg)
24. Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Ashley Hoedt, MS; 9289634445; ahoedt@wlgore.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02777593
• Other Study ID Numbers: SSB 11-02 Pivotal (Zone 2)
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: W.L.Gore & Associates
• Study Sponsor: W.L.Gore & Associates
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael M Dake, MD; Stanford University
• Principal Investigator: Himanshu Patel, MD; University of Michigan

• PRS Account: W.L.Gore & Associates
• Verification Date: February 2020