Aortic Aneurysm, ThoracicNCT02021812
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
A study testing GORE® TAG® Thoracic Branch Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 6 sites in United States.
Trial summary
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- GORE® TAG® Thoracic Branch Endoprosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2014to Mar 2022
- 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 DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 2:
- Fusiform (≥ 55 mm), or
- Fusiform (>2 times native aortic diameter), or
- Saccular (no diameter criteria)
- Age ≥18 years at time of informed consent signature
- Subject is capable of complying with protocol requirements, including follow-up
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- Informed Consent Form (ICF) is signed by Subject or legal representative
- Must have appropriate proximal aortic landing zone, defined as:
- Must require coverage of the left subclavian artery (LSA) origin for exclusion of the lesion
- Aortic inner diameters between 16-48 mm
- Landing zone, which must include the LSA ostium, cannot be aneurysmal, heavily calcified, or heavily thrombosed,
- Acceptable proximal landing zone outer curvature length for the required device
- Landing zone must be native aorta
- Must have appropriate distal aortic landing zone, defined as:
- Outer curvature length must be ≥2cm proximal to the celiac artery
- Aortic inner diameters between 16-48mm (diameter should be between 16-42mm if using distal TAG® Device extension)
- Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
- Native aorta or previously implanted GORE® TAG® Device
- Must have appropriate LSA landing zone, defined as:
- LSA length of ≥3 cm proximal to first major branch vessel if using Aortic Component with 8 mm portal diameter, or LSA length of ≥2.5 cm proximal to first major branch vessel if using Aortic Component with 12 mm portal diameter
- LSA inner diameters of 6-15 mm if using Aortic Component with 8 mm portal diameter, or inner diameters of 11-18 mm if using Aortic Component with 12 mm portal diameter
- Target branch vessel landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed
Who cannot join
- Concomitant aneurysm/disease of the ascending aorta, aortic arch, or 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 of treatment
- Infected aorta
- Dissection of the DTA
Show all 31Show fewer
- Intramural hematoma of the DTA without DTA aneurysm
- Life expectancy <2 years
- Myocardial infarction or stroke within 6 weeks prior to treatment
- 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
- Significant thrombus or atheroma in the aortic arch
- 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 left carotid or celiac arteries
- 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
- 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
- Additionally, the following exclusion criteria apply for Subjects enrolled in Stage 1:
- Aberrant right subclavian or left vertebral arteries
- Occluded/stenosed/hypoplastic right vertebral artery
- Presence of a patent left internal mammary artery (LIMA) graft
- Bilateral carotid artery disease
- Known incomplete Circle of Willis
- Known left vertebral artery ending in posterior inferior cerebellar artery (PICA)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
The Hitchcock Foundation (Dartmouth Hitchcock Medical Center)
Lebanon, New Hampshire, 03756
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Leland Stanford Junior University
Stanford, California, 94305-5407
About this study
Official title: Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
Read the detailed description
The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG Device are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular-only treatment options for patients with aneurysms approaching the aortic arch are limited as current stent graft technology would require coverage of the left subclavian artery (LSA) which may result in the need for a surgical revascularization procedure. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was evaluated in this study under IDE G130120 for Zone 2 aneurysms of the DTA.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- GORE® TAG® Thoracic Branch Endoprosthesis
- 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
| Study group | Role | What they receive |
|---|---|---|
| Branched TAG® Device | Experimental | Treatment with the GORE® TAG® Thoracic Branch Endoprosthesis Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Successful Study Device Access
Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Measured: During treatment procedure (day 0)
Number of Participants With Successful Study Device Deployment
Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.
Measured: During treatment procedure (day 0)
Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography
The presence of forward flow through the implanted Side Branch Component into the target branch vessel.
Measured: At conclusion of the treatment procedure (day 0)
Secondary outcomes (2)
Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
Measured: 1 Month
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
Device-related endoelaks are defined as the presence of contrast within the aneurysm sac originating from the junction between any Branched TAG® Device component and the adjacent tissue (endoleak type IA or IB) OR the junction between the Aortic Component and either the SB Component or the Aortic Extender (type III endoleak).
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2016
- Study completionMar 2022
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.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Dake, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021812
- Sponsor's protocol ID
- SSB 11-02
- Status last verified
- Aug 2022
- First submitted
- 13 Dec 2013
- Last updated
- 9 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis in the Treatment of Proximal Descending Thoracic Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT02021812
- Acronym / sponsor ID
- SSB 11-02
- Conditions
- Aortic Aneurysm, Thoracic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
Detailed description
The GORE® TAG® Thoracic Endoprosthesis (TAG® Device) received premarket approval (PMA) for use in endovascular aneurysm repair of the descending thoracic aorta (DTA) on 23-Mar-2005 under P040043, and design changes that resulted in the conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device) received premarket approval for the treatment of aneurysms of the DTA on 23-Aug-2011 (P040043/S039). The TAG® Device and CTAG Device are intended to exclude an aneurysm from the blood circulation in patients diagnosed with DTA aneurysms. However, endovascular-only treatment options for patients with aneurysms approaching the aortic arch are limited as current stent graft technology would require coverage of the left subclavian artery (LSA) which may result in the need for a surgical revascularization procedure. This prompted the creation of the GORE® TAG® Thoracic Branch Endoprosthesis (previously known as Branched TAG® Device), which was evaluated in this study under IDE G130120 for Zone 2 aneurysms of the DTA.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Branched TAG® Device | Experimental | Device: GORE® TAG® Thoracic Branch EndoprosthesisTreatment with the GORE® TAG® Thoracic Branch Endoprosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Presence of DTA aneurysm deemed to warrant surgical repair which requires proximal graft placement in Zone 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, defined as:
Key exclusion criteria (31 listed)
- Concomitant aneurysm/disease of the ascending aorta, aortic arch, or 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 of treatment
- 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 Endoprosthesis | Device | Branched TAG® Device |
Primary outcome
Number of Participants With Successful Study Device Access
Time frame: During treatment procedure (day 0)
Access to the aneurysm and target landing zone location is obtained via conventional vascular access and endovascular techniques.
Number of Participants With Successful Study Device Deployment
Time frame: During treatment procedure (day 0)
Absence of deployment failure will be considered a successful deployment. Deployment failure will be considered the failure of any Branched TAG® Device component (Aortic Component, Aortic Extender, or SB Component) to be released from the delivery catheter resulting in a serious adverse event (SAE) due to mechanical failure or use error.
Number of Participants With Primary Procedural Side Branch Patency as Assessed by Angiography
Time frame: At conclusion of the treatment procedure (day 0)
The presence of forward flow through the implanted Side Branch Component into the target branch vessel.
2 secondary outcomes
Number of Participants With 1 Month Side Branch Primary Patency Assessed by an Independent Core Lab
Time frame: 1 Month
Number of Participants Without 1 Month Device Related Endoleaks Assessed by an Independent Core Lab
Time frame: 1 Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 D Dake, MD principal investigator
Stanford University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GORE® TAG® Thoracic Branch Endoprosthesis in people with Aortic Aneurysm, Thoracic, run by W.L.Gore & Associates at 6 sites in United States.
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 22 inclusion and 31 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: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 2 Aug 2017). 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?
Number of Participants With Successful Study Device Access (time frame: During treatment procedure (day 0)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.