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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02777593
Other study ID # SSB 11-02 Pivotal (Zone 2)
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 6, 2016
Est. completion date December 2027

Study information

Verified date October 2023
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, requiring Zone 2 proximal implantation of the device.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

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
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