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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02777528
Other study ID # SSB 11-02 Pivotal (Zone 0/1)
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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