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SSB 11-02: 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)

Sponsor
W.L.Gore & Associates (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02777593
Collaborator
(none)
315
Enrollment
40
Locations
2
Arms
124
Duration (Months)
7.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: GORE® TAG® Thoracic Branch Endoprosthesis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
315 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Aug 1, 2016
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Zone 2 Aortic aneurysm - CLOSED TO ENROLLMENT

Zone 2 Aortic Aneurysm

Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device
Other: Zone 2 Non-aneurysm aortic lesions

Includes dissection, traumatic transection and other isolated lesion types

Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device

Outcome Measures

Primary Outcome Measures

  1. Composite of technical success and adverse events for Zone 2 Subjects (Aneurysm Cohort) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Arizona Heart Institute Phoenix Arizona United States 85006
3 Keck Medical Center of USC Los Angeles California United States 90033
4 Cedar-Sinai Medical Center Los Angeles California United States 90048
5 University of California - Los Angeles Los Angeles California United States 90095
6 Leland Stanford Junior University Stanford California United States 94305-5407
7 Hartford Hospital Hartford Connecticut United States 06106
8 MedStar Health Research Institute Washington District of Columbia United States 20010
9 University of Florida - Gainesville Gainesville Florida United States 32610
10 Univeristy of South Florida Tampa Florida United States 33606
11 Emory University Atlanta Georgia United States 30322
12 Northwestern University Chicago Illinois United States 60611
13 St. Vincent Medical Group, Inc. Indianapolis Indiana United States 46290
14 University of Louisville Jewish Hospital Louisville Kentucky United States 40202
15 University or Maryland Baltimore Baltimore Maryland United States 21201
16 Massachusetts General Hospital Boston Massachusetts United States 02114
17 University of Michigan Ann Arbor Michigan United States 48109
18 William Beaumont Hospital Royal Oak Michigan United States 48073
19 Mayo Clinic Rochester Rochester Minnesota United States 55905
20 Washington University School of Medicine Saint Louis Missouri United States 63110
21 Dartmouth-Hitchcock Medical Center Lebanon New Hampshire United States 03766
22 Cooper University Hospital Camden New Jersey United States 08103
23 Research Foundation SUNY Buffalo Buffalo New York United States 14203
24 Carolinas HealthCare Systems Charlotte North Carolina United States 28203
25 Duke University Medical Center Durham North Carolina United States 27710
26 Cleveland Clinic Cleveland Ohio United States 44195
27 Oregon Health & Science University Portland Oregon United States 97239
28 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
29 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15232
30 Cardiovascular Surgery Clinic Memphis Tennessee United States 38120
31 Vanderbilt University Medical Center Nashville Tennessee United States 37232
32 Cardiothoracic and Vascular Surgeons Austin Texas United States 78756
33 Baylor College of Medicine - Houston Houston Texas United States 77030
34 Houston Methodist Hospital Houston Texas United States 77030
35 Memorial Hermann Houston Texas United States 77030
36 Heart Hospital at Baylor Plano Plano Texas United States 75093
37 University of Virginia Charlottesville Virginia United States 22908
38 Sentara Medical Group Norfolk Virginia United States 23507
39 University of Washington Seattle Washington United States 98195
40 University of Wisconsin System Madison Wisconsin United States 53792

Sponsors and Collaborators

  • W.L.Gore & Associates

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT02777593
Other Study ID Numbers:
  • SSB 11-02 Pivotal (Zone 2)
First Posted:
May 19, 2016
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic

Study Results

No Results Posted as of Feb 9, 2022