Aortic Aneurysm, Thoracic Clinical Trial
— SSB 11-02Official title:
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
Verified date | May 2024 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
United States, Japan,
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 |
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