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, Zone 2
Verified date | October 2023 |
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, requiring Zone 2 proximal implantation of the device.
Status | Active, not recruiting |
Enrollment | 250 |
Est. completion date | December 2027 |
Est. primary completion date | April 12, 2021 |
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. 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 |
Country | Name | City | State |
---|---|---|---|
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 or Maryland Baltimore | 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 | Northwestern 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-Hitchcock 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 Louisville Jewish Hospital | Louisville | Kentucky |
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 | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | University of Washington | Seattle | Washington |
United States | Leland Stanford Junior University | Stanford | California |
United States | Univeristy of South Florida | Tampa | Florida |
United States | MedStar Health Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Participants With Primary Endpoint Success for Zone 2 | 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. | 12 Months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02876263 -
Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta
|
N/A | |
Terminated |
NCT02538822 -
Risk of Rupture of Aneurysms of the Thoracic Ascending Aorta (ATA) From the Dynamic Imaging
|
N/A | |
Completed |
NCT04930172 -
TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
|
||
Completed |
NCT03207568 -
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
|
N/A | |
Recruiting |
NCT03010514 -
A Registry Study on Genetics and Biomarkers of Thoracic Aortic Aneurysm/Dissection
|
N/A | |
Completed |
NCT02266342 -
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
|
||
Completed |
NCT00757003 -
To Evaluate the Safety and Efficacy for GORE TAG Thoracic Endoprosthesis in the Treatment of Thoracic Aortic Disease
|
Phase 3 | |
Recruiting |
NCT03574311 -
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
|
Phase 4 | |
Suspended |
NCT03410420 -
Detection of Hypoxia in Human Thoracic Aorta Using Pimonidazole Hydrochloride
|
Phase 1 | |
Recruiting |
NCT05703893 -
Investigation of the Neurovegetative Pattern in Patients With Thoracic Aortic Aneurysms (TAA)
|
||
Enrolling by invitation |
NCT05800743 -
Evaluation of the GORE® Ascending Stent Graft
|
N/A | |
Completed |
NCT02253082 -
Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas Trial (EudraCT no. 2014-000452-28)
|
Phase 4 | |
Recruiting |
NCT02323581 -
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
|
N/A | |
Active, not recruiting |
NCT03414866 -
Thoraflex Hybrid Post-Market Study
|
||
Recruiting |
NCT01985906 -
Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair
|
N/A | |
Active, not recruiting |
NCT02818972 -
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
|
N/A | |
Completed |
NCT03479164 -
Development of Ultra-Low Dose CT Based Screening for Aortic Aneurysms
|
N/A | |
Completed |
NCT01775046 -
Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
|
||
Recruiting |
NCT04814238 -
Minimally Invasive Aortic Root and Aorta surGery rEgistry
|
||
Completed |
NCT01756911 -
Evaluation of the Safety and Efficacy of the Multilayer Stent
|
N/A |