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

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ClinicalTrials.gov Identifier: NCT02777593
Recruitment Status : Active, not recruiting
First Posted : May 19, 2016
Results First Posted : November 22, 2022
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

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, requiring Zone 2 proximal implantation of the device.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Aorta; Lesion Device: GORE® TAG® Thoracic Branch Endoprosthesis Not Applicable

Detailed Description:
For Zone 2, there are two arms (Aneurysm arm, Non-aneurysm arm) and four cohorts, described as follows: Zone 2 Aneurysm, Zone 2 Dissection, Zone 2 Traumatic Transection, and Zone 2 Other Isolated Lesion. Continued access Subjects were enrolled in the Zone 2 Aneurysm arm. The Zone 2 Aneurysm cohort was the only cohort analyzed with a hypothesis test, however data was collected similarly for all cohorts and for continued access Subjects. Zone 2 Subjects enrolled for analysis were from the United States only.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Non-Randomized
Intervention Model: Single Group 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, Zone 2
Actual Study Start Date : September 6, 2016
Actual Primary Completion Date : April 12, 2021
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Zone 2 Aneurysm
Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device

Zone 2 Non-aneurysm
Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Device: GORE® TAG® Thoracic Branch Endoprosthesis
Endovascular repair with the TBE Device




Primary Outcome Measures :
  1. Proportion of Participants With Primary Endpoint Success for Zone 2 [ Time Frame: 12 Months ]
    Primary Endpoint was composite of the following events: device technical success and absence of 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/withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777593


Locations
Show Show 35 study locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Michael M Dake, MD Stanford University
Principal Investigator: Himanshu Patel, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by W.L.Gore & Associates:
Study Protocol  [PDF] November 23, 2020
Statistical Analysis Plan  [PDF] March 19, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Results First Posted: November 22, 2022
Last Update Posted: November 22, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases