Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)

Aortic Aneurysm, Thoracic Clinical Trial

— SSB 11-02  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02777528
• Other study ID #: SSB 11-02 Pivotal (Zone 0/1)
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: March 2028
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

8. Native aortic valve (Zone 0/1 subjects only)

9. Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)

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

26. Patient at high risk of neurological event, e.g. stroke

Related Conditions & MeSH terms

• Aneurysm
• Aorta, Lesion
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic

Intervention

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

Procedure:
• Revascularization Procedure
Revascularization procedure of the great vessel

Locations

Country	Name	City	State
Japan	Nagoya University Hospital	Aichi
Japan	Oita University Hospital	Oita
Japan	Morinomiya Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Jikei Medical University Hospital	Tokyo
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Cardiothoracic and Vascular Surgeons	Austin	Texas
United States	University of Baltimore Maryland	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Research Foundation SUNY Buffalo	Buffalo	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Carolinas HealthCare Systems	Charlotte	North Carolina
United States	Northwesten University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida-Gainesville	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine - Houston	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Memorial Hermann	Houston	Texas
United States	St. Vincent Medical Group, Inc.	Indianapolis	Indiana
United States	Dartmouth-Hitchock Medical Center	Lebanon	New Hampshire
United States	Cedar-Sinai Medical Center	Los Angeles	California
United States	Keck Medical Center of USC	Los Angeles	California
United States	University of Wisconsin System	Madison	Wisconsin
United States	Cardiovascular Surgery Clinic	Memphis	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Sentara Medical Group	Norfolk	Virginia
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Heart Hospital at Baylor Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington Univeristy School of Medicine - St Louis	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington
United States	Leland Stanford Junior University	Stanford	California
United States	University of South Florida	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort)	Composite of the following events through one month: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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.	1 month
Primary	Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort)	Composite of the following events through twelve months: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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.	12 months