Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1) (SSB 11-02)
Primary Purpose
Aortic Aneurysm, Thoracic, Aorta, Lesion
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
GORE® TAG® Thoracic Branch Endoprosthesis
Revascularization Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Thoracic
Eligibility Criteria
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.
- Native aortic valve (Zone 0/1 subjects only)
- 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:
- 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
- Patient at high risk of neurological event, e.g. stroke
Sites / Locations
- Keck Medical Center of USC
- Cedar-Sinai Medical Center
- Leland Stanford Junior University
- Hartford Hospital
- MedStar Washington Hospital Center
- University of Florida-Gainesville
- University of South Florida
- Emory University
- Northwesten University
- St. Vincent Medical Group, Inc.
- University of Baltimore Maryland
- Massachusetts General Hospital
- University of Michigan
- Mayo Clinic
- Washington Univeristy School of Medicine - St Louis
- Dartmouth-Hitchock Medical Center
- Cooper University Hospital
- Research Foundation SUNY Buffalo
- Carolinas HealthCare Systems
- Duke University Medical Center
- Cleveland Clinic
- Oregon Health & Science University
- Hospital of the University of Pennsylvania
- University of Pittsburgh Medical Center
- Cardiovascular Surgery Clinic
- Vanderbilt University Medical Center
- Cardiothoracic and Vascular Surgeons
- Baylor College of Medicine - Houston
- Houston Methodist Hospital
- Memorial Hermann
- Heart Hospital at Baylor Plano
- Sentara Medical Group
- University of Washington
- University of Wisconsin System
- Nagoya University Hospital
- Oita University Hospital
- Morinomiya Hospital
- Osaka University Hospital
- Jikei Medical University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Zone 0/1 Aortic aneurysm
Zone 0/1 Non-aneurysm aortic lesions
Arm Description
Zone 0/1 Aortic aneurysm
Includes dissection and other isolated lesion types
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02777528
Brief 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 0/1)
Acronym
SSB 11-02
Official Title
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracic, Aorta, Lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Zone 0/1 Aortic aneurysm
Arm Type
Other
Arm Description
Zone 0/1 Aortic aneurysm
Arm Title
Zone 0/1 Non-aneurysm aortic lesions
Arm Type
Other
Arm Description
Includes dissection and other isolated lesion types
Intervention Type
Device
Intervention Name(s)
GORE® TAG® Thoracic Branch Endoprosthesis
Intervention Description
Endovascular repair with the TBE Device
Intervention Type
Procedure
Intervention Name(s)
Revascularization Procedure
Intervention Description
Revascularization procedure of the great vessel
Primary Outcome Measure Information:
Title
Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort)
Description
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.
Time Frame
1 month
Title
Composite of Initiation of Index Procedure, Device Technical Success and Adverse Events for Zone 0/1 Subjects (Aneurysm Cohort)
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Native aortic valve (Zone 0/1 subjects only)
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:
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
Patient at high risk of neurological event, e.g. stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Dake, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Himanshu Patel, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Medical Center of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedar-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Leland Stanford Junior University
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5407
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Florida-Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwesten University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. Vincent Medical Group, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Baltimore Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington Univeristy School of Medicine - St Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Research Foundation SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Carolinas HealthCare Systems
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cardiovascular Surgery Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cardiothoracic and Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Baylor College of Medicine - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Heart Hospital at Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin System
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Nagoya University Hospital
City
Aichi
Country
Japan
Facility Name
Oita University Hospital
City
Oita
Country
Japan
Facility Name
Morinomiya Hospital
City
Osaka
Country
Japan
Facility Name
Osaka University Hospital
City
Osaka
Country
Japan
Facility Name
Jikei Medical University Hospital
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1)
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