Aortic Aneurysm, ThoracicSSB 11-02NCT02777528

Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1

A study testing GORE® TAG® Thoracic Branch Endoprosthesis and Revascularization Procedure in people with Aortic Aneurysm, Thoracic and Aorta, Lesion, run by W.L.Gore & Associates at 39 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Aneurysm, Thoracic, Aorta, Lesion
What is being tested?: GORE® TAG® Thoracic Branch Endoprosthesis and Revascularization Procedure
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 39 sitesin 2 countries
Study dates: Aug 2016to Mar 2028
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 9Show fewer

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)

Who cannot join

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

Show all 26Show fewer

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

Trial locations and contacts

39 sites in 2 countries.

Country

City, postcode or hospital

39 sites in 2 countries

United States34 sites

University of Michigan
Ann Arbor, Michigan, 48109
Emory University
Atlanta, Georgia, 30322
Cardiothoracic and Vascular Surgeons
Austin, Texas, 78756
University of Baltimore Maryland
Baltimore, Maryland, 21201
Massachusetts General Hospital
Boston, Massachusetts, 02114
Research Foundation SUNY Buffalo
Buffalo, New York, 14203
Cooper University Hospital
Camden, New Jersey, 08103
Carolinas HealthCare Systems
Charlotte, North Carolina, 28203
Northwesten University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida-Gainesville
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06106
Baylor College of Medicine - Houston
Houston, Texas, 77030
Houston Methodist Hospital
Houston, Texas, 77030
Memorial Hermann
Houston, Texas, 77030
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46290
Dartmouth-Hitchock Medical Center
Lebanon, New Hampshire, 03766
Keck Medical Center of USC
Los Angeles, California, 90033
Cedar-Sinai Medical Center
Los Angeles, California, 90048
University of Wisconsin System
Madison, Wisconsin, 53792
Cardiovascular Surgery Clinic
Memphis, Tennessee, 38120
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Sentara Medical Group
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Heart Hospital at Baylor Plano
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington
Seattle, Washington, 98195
Washington Univeristy School of Medicine - St Louis
St Louis, Missouri, 63110
Leland Stanford Junior University
Stanford, California, 94305-5407
University of South Florida
Tampa, Florida, 33606
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010

Other trials in United States

Japan5 sites

Nagoya University Hospital
Aichi
Oita University Hospital
Ōita
Morinomiya Hospital
Osaka
Osaka University Hospital
Osaka
Jikei Medical University Hospital
Tokyo

Other trials in Japan

About this study

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, Zone 0/1

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.

Read the detailed description

For Zone 0/1, there are two arms (Aneurysm arm, Non-aneurysm arm) and three cohorts, described as follows: Zone 0/1 Aneurysm, Zone 0/1 Dissection, and Zone 0/1 Other Isolated Lesion. The Zone 0/1 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 0/1 Subjects enrolled for analysis were from the United States and Japan.

Conditions: Aortic Aneurysm, Thoracic, Aorta, Lesion
Being tested: GORE® TAG® Thoracic Branch Endoprosthesis, Revascularization Procedure
Medical subject headings: Aortic Aneurysm, Thoracic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GORE® TAG® Thoracic Branch EndoprosthesisDevice
Endovascular repair with the TBE Device
Revascularization ProcedureProcedure or surgery
Revascularization procedure of the great vessel

Study groups in NCT02777528
Study group	Role	What they receive
Zone 0/1 Aortic aneurysm	Other	Zone 0/1 Aortic aneurysm Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis; Procedure: Revascularization Procedure
Zone 0/1 Non-aneurysm aortic lesions	Other	Includes dissection and other isolated lesion types Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis; Procedure: Revascularization Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Measured: 1 month
Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1
Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Mar 2028

First posted19 May 2016 (estimated)
Study startAug 2016
Primary completionMar 2024
Study completionMar 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Aortic Aneurysm, ThoracicStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02777528
Sponsor's protocol ID: SSB 11-02 Pivotal (Zone 0/1)
Acronym: SSB 11-02
Status last verified: Aug 2026
First submitted: 12 May 2016
Last updated: 10 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Sweet MP, Azizzadeh A, Oderich GS, Brinkman W, Matsumura JS, Ohki T, Zettervall S, Miyamoto S, Patel HJ, Dake MD. Early outcomes of endovascular repair of aortic arch lesions in zone 0/1 with a thoracic branched endoprosthesis. J Vasc Surg. 2025 Nov;82(5):1591-1600.e4. doi: 10.1016/j.jvs.2025.07.040. Epub 2025 Jul 30.
PubMed 40749959

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Recruiting
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
Aortic Arch Dissection, Aortic Arch Aneurysm
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingPhase 4
Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery
Aortic Aneurysm of the Proximal Arch, Aortic Aneurysms Arch
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

All Aortic Aneurysm, Thoracic trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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, Zone 0/1
ClinicalTrials.gov ID: NCT02777528
Acronym / sponsor ID: SSB 11-02 / SSB 11-02 Pivotal (Zone 0/1)
Conditions: Aortic Aneurysm, Thoracic, Aorta, Lesion
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 79 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Mar 2024 (actual)
Study completion: Mar 2028 (estimated)
First posted: 19 May 2016 (estimated)
Results: Posted 25 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Zone 0/1 Aortic aneurysm	Other	Device: GORE® TAG® Thoracic Branch Endoprosthesis, Procedure: Revascularization ProcedureZone 0/1 Aortic aneurysm
Zone 0/1 Non-aneurysm aortic lesions	Other	Device: GORE® TAG® Thoracic Branch Endoprosthesis, Procedure: Revascularization ProcedureIncludes dissection and other isolated lesion types

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (26 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GORE® TAG® Thoracic Branch EndoprosthesisEndovascular repair with the TBE Device	Device	Zone 0/1 Aortic aneurysm, Zone 0/1 Non-aneurysm aortic lesions
Revascularization ProcedureRevascularization procedure of the great vessel	Procedure or surgery	Zone 0/1 Aortic aneurysm, Zone 0/1 Non-aneurysm aortic lesions

Primary outcome

Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1
Time frame: 1 month
Primary Endpoint was composite of the following events from the time of enrollment through one month following the endovascular procedure (through day 59 unless otherwise specified): initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.
Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1
Time frame: 12 months
Primary Endpoint was composite of the following events from the time of enrollment through twelve months following the endovascular procedure: initiation of the index endovascular procedure following the debranching procedure, device technical success for the index endovascular procedure 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, or withdrawal of the delivery system. Limited to 30 days: disabling stroke, permanent paraplegia, permanent paraparesis, new onset renal failure requiring permanent dialysis.

Results and safety

Results posted to the registry on 25 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Zone 0/1 Aneurysm Cohort	52	6
Zone 0/1 Dissection Cohort	24	4
Zone 0/1 Other Isolated Lesion Cohort	3	0

Primary outcome: Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1

Time frame: 1 month. Number. Unit: proportion of participants

Measure	Zone 0/1 Aneurysm Cohort n = 47	Zone 0/1 Dissection Cohort n = 22	Zone 0/1 Other Isolated Lesion Cohort n = 3
Value	0.745	0.818	1.0

Zone 0/1 Aneurysm Cohort: 95% Exact Lower Confidence Limit: 0.745

Population analysed: Two Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified due to treatment with 49/53 mm devices no longer supported by the protocol. Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 1 Month window.

Primary outcome: Proportion of Participants With Primary Endpoint Success Through 12 Months for Zone 0/1

Time frame: 12 months. Number. Unit: proportion of participants

Measure	Zone 0/1 Aneurysm Cohort n = 44	Zone 0/1 Dissection Cohort n = 24	Zone 0/1 Other Isolated Lesion Cohort n = 2
Value	0.727	0.750	1.0

Population analysed: Two Zone 0/1 Aneurysm participants that are counted in the Participant Flow section above are excluded from this analysis, as pre-specified, due to treatment with 49/53 devices no longer supported by the protocol. Primary Endpoint composite denominator was restricted to number of participants either with a primary endpoint event or imaging performed in the 12 Month window.

Adverse events

Time frame: Adverse events collected for 60 Months, rates shown are through 12-months follow-up, follow-up is ongoing for participants who have not completed the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Zone 0/1 Aneurysm Cohort	43 of 52 (82.7%)	40 of 52 (76.9%)	14 of 52
Zone 0/1 Dissection Cohort	19 of 24 (79.2%)	21 of 24 (87.5%)	7 of 24
Zone 0/1 Other Isolated Lesion Cohort	1 of 3 (33.3%)	2 of 3 (66.7%)	1 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40749959Sweet MP, Azizzadeh A, Oderich GS, Brinkman W, Matsumura JS, Ohki T, Zettervall S, Miyamoto S, Patel HJ, Dake MD. Early outcomes of endovascular repair of aortic arch lesions in zone 0/1 with a thoracic branched endoprosthesis. J Vasc Surg. 2025 Nov;82(5):1591-1600.e4. doi: 10.1016/j.jvs.2025.07.040. Epub 2025 Jul 30.

Related trials for Aortic Aneurysm, Thoracic

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Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Dake, MD principal investigator

Stanford University

Himanshu Patel, MD principal investigator

University of Michigan

39 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Primary Endpoint Success Through 1 Month for Zone 0/1 (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02777528, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.