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)

Tracking Information
First Submitted Date ICMJE	May 12, 2016
First Posted Date ICMJE	May 19, 2016
Last Update Posted Date	July 19, 2018
Study Start Date ICMJE	August 2016
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (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 ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02777593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	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 ICMJE	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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Aortic Aneurysm, Thoracic; Aorta; Lesion
Intervention ICMJE	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
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: May 16, 2016)	285
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2023
Estimated Primary Completion Date	July 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.; Age ≥18 years at time of informed consent signature; Subject is capable of complying with protocol requirements, including follow-up; Informed Consent Form (ICF) is signed by Subject or legal representative; Must have appropriate proximal aortic landing zone.; Must have appropriate target branch vessel landing zone; For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone. Exclusion Criteria: Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair; Previous endovascular repair of the ascending aorta; Previous endovascular repair of the DTA with a non-Gore device; Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access; Infected aorta; Life expectancy <2 years; Myocardial infarction within 6 weeks prior to treatment; 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.; Patient has a systemic infection and may be at increased risk of endovascular graft infection; Pregnant female at time of informed consent signature; Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome; Participation in another drug or medical device study within one year of study enrollment; Known history of drug abuse within one year of treatment; Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta; Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access; Planned coverage of celiac artery; Patient has known sensitivities or allergies to the device materials; Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment; Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin; Patient with a history of a hypercoagulability disorder and/or hypercoagulability state; 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; Mycotic aneurysm; Persistent refractory shock (systolic blood pressure <90 mm Hg); Patient has body habitus or other medical condition which prevents adequate visualization of the aorta; 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 ICMJE	Contact: Nick Pirooz, MHA 623-234-5519 npriooz@wlgore.com
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02777593
Other Study ID Numbers ICMJE	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 ICMJE	W.L.Gore & Associates
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Michael M Dake, MD Stanford University Principal Investigator: Himanshu Patel, MD University of Michigan
PRS Account	W.L.Gore & Associates
Verification Date	July 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP