Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2

Not Applicable

Active, not recruiting

Conditions: Aortic Aneurysm, Thoracic
Aorta; Lesion

Interventions: Device: GORE® TAG® Thoracic Branch Endoprosthesis

Registration Number: NCT02777593

Lead Sponsor: W.L.Gore & Associates

Brief 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.

Detailed 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 & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 250

Inclusion Criteria

Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
Age ≥18 years at time of informed consent signature
Subject is capable of complying with protocol requirements, including follow-up
Informed Consent Form (ICF) is signed by Subject or legal representative
Must have appropriate proximal aortic landing zone.
Must have appropriate target branch vessel landing zone
For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.

Exclusion Criteria

Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
Previous endovascular repair of the ascending aorta
Previous endovascular repair of the DTA with a non-Gore device
Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access
Infected aorta
Life expectancy <2 years
Myocardial infarction within 6 weeks prior to treatment
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.
Patient has a systemic infection and may be at increased risk of endovascular graft infection
Pregnant female at time of informed consent signature
Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
Participation in another drug or medical device study within one year of study enrollment
Known history of drug abuse within one year of treatment
Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
Planned coverage of celiac artery
Patient has known sensitivities or allergies to the device materials
Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
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
Mycotic aneurysm
Persistent refractory shock (systolic blood pressure <90 mm Hg)
Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zone 2 Non-aneurysm	GORE® TAG® Thoracic Branch Endoprosthesis	Includes dissection, traumatic transection and other isolated aortic lesion cohorts. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.
Zone 2 Aneurysm	GORE® TAG® Thoracic Branch Endoprosthesis	Includes primary (hypothesis-driven) aneurysm cohort and continued access. Subjects enrolled for treatment with the TBE device with proximal implantation in aortic Zone 2.

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With Primary Endpoint Success for Zone 2	12 Months	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (35): Cooper University Hospital
🇺🇸
Camden, New Jersey, United States
Cedar-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Baylor College of Medicine - Houston
🇺🇸
Houston, Texas, United States
Houston Methodist Hospital
🇺🇸
Houston, Texas, United States
University of Washington
🇺🇸
Seattle, Washington, United States
University or Maryland Baltimore
🇺🇸
Baltimore, Maryland, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
St. Vincent Medical Group, Inc.
🇺🇸
Indianapolis, Indiana, United States
Keck Medical Center of USC
🇺🇸
Los Angeles, California, United States
Leland Stanford Junior University
🇺🇸
Stanford, California, United States
MedStar Health Research Institute
🇺🇸
Washington, District of Columbia, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
University of Florida - Gainesville
🇺🇸
Gainesville, Florida, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Univeristy of South Florida
🇺🇸
Tampa, Florida, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of Louisville Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Carolinas HealthCare Systems
🇺🇸
Charlotte, North Carolina, United States
Research Foundation SUNY Buffalo
🇺🇸
Buffalo, New York, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Cardiovascular Surgery Clinic
🇺🇸
Memphis, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Cardiothoracic and Vascular Surgeons
🇺🇸
Austin, Texas, United States
Memorial Hermann
🇺🇸
Houston, Texas, United States
Heart Hospital at Baylor Plano
🇺🇸
Plano, Texas, United States
Sentara Medical Group
🇺🇸
Norfolk, Virginia, United States
University of Wisconsin System
🇺🇸
Madison, Wisconsin, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States