AneurysmNCT06507865
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
An observational study of Aneurysm and Dissection, Aortic, run by W.L.Gore & Associates at 19 sites in 9 countries.
Trial summary
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm, Dissection, Aortic, TAA Thoracoabdominal Aortic Aneurysm
- What is being tested?
- GORE® TAG® Thoracic Branch Endoprosthesis
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 19 sitesin 9 countries
- Study dates
- 20 Feb 2025to Mar 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
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
Study population: Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with TBE at participating sites. Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry. The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a TBE product has been made prior to considering the patient for possible registry participation. The TBE registry population will be defined as a successful recipient of TBE at the end of the index procedure.
Who may be able to join
- Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.
Who cannot join
- Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
- Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Trial locations and contacts
19 sites in 9 countries.
19 sites in 9 countries
Italy5 sites
Policlinico di Sant'Orsola
Bologna, 40138
ASST Spedali Civili di Brescia
Brescia, 25123
Azienda Ospedaliera "G. Brotzu"
Cagliari
IRCCS Ospedale Policlinico San Martino
Genova, 16132
AOU Padova
Padova, 35128
Germany4 sites
Klinik für Gefäßmedizin, Universitätsklinikum Hamburg-Eppendorf
Hamburg
University of Heidelberg
Heidelberg, 69120
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
Universitätsklinikum Münster
Münster, 48149
Greece2 sites
Evangelismos General Hospital
Athens, 106 76
Laiko General hospital of Athens
Athens, 11527
Netherlands2 sites
Amsterdam UMC
Amsterdam, 1105 AZ
Radboud UMC
Nijmegen, 6525 GA
United Kingdom2 sites
St Thomas' Hospital
London, SE1 7EH
St Mary's Hospital
London, W2 1NY
About this study
Official title: Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.
Read the detailed description
The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.
Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
- Conditions
- Aneurysm, Dissection, Aortic, TAA Thoracoabdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Transection Aorta
- Being tested
- GORE® TAG® Thoracic Branch Endoprosthesis
- Keywords
- TEVAR, Aneurysm, Dissection, Aorta, Endovascular stent graft, Thoracic branch endoprosthesis
- Medical subject headings
- Aneurysm, Aortic Dissection, Aortic Aneurysm, Thoracoabdominal, 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
Also called TBE device
Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum.
| Study group | Role | What they receive |
|---|---|---|
| GORE® TAG® Thoracic Branch Endoprosthesis | Patients treated with the TBE Device Receives: Device: GORE® TAG® Thoracic Branch Endoprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deployment Technical Success
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. The absence of any additional corrective procedure related to the device, procedure, or withdrawal of the delivery system. Events will not include interventions at the access site(s), lumbar drains to address spinal cord ischemia, or additional interventions to address non-treatment areas.
Measured: Time of Surgery
Lesion-related Mortality
Death related to the index endovascular procedure or following conversion to open repair and death related to a complication from a secondary procedure associated with the index lesion or registry device.
Any death where the treated disease / index lesion or registry device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.
Measured: Day 30 through Year 2
Lesion Rupture (treated area)
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Measured: Time of Surgery through Year 2
Lesion Enlargement (treated area)
An increase in maximum vessel (e.g., aorta or treated branch) diameter of > 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CT / CTA scans.
Measured: Time of Surgery through Year 2
Endoleaks (Type I-V)
Perfusion of a treated lesion identified through imaging analysis.
Measured: Time of Surgery through Year 2
Device Migration
Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.
Measured: Time of Surgery through Year 2
Loss of Aortic / Branch Patency
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Measured: Time of Surgery through Year 2
Stroke
Stroke is the acute onset of symptoms consistent with focal or multifocal central nervous system (CNS) injury caused by vascular blockage resulting in ischemia or vascular rupture resulting in hemorrhage, that either persists for > 24 hours or until death or symptoms lasting < 24 hours, with pathology or neuroimaging confirmation of CNS infarction.
Measured: Time of Surgery through Year 2
Paraplegia
New onset spinal cord injury rendering a subject non-ambulatory.
Measured: Time of surgery through Day 30
Paraparesis
New onset spinal cord injury causing a minor motor deficit of the lower extremities.
Measured: Time of surgery through Day 30
New Onset Renal Failure
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for > 4 weeks.
Measured: Time of surgery through Day 30
Renal Function Deterioration
New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.
Measured: Time of surgery through Year 2
Device Integrity Events
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis.
Measured: Time of Surgery through Year 2
Reintervention
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.
This may include surgical or interventional treatment for endoleaks, access site(s) complications, disease progression (including interventions to address issues related to non-treated area of the index lesion, such as bare stent implantation to address bowel ischemia associated with aortic dissection), spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery.
Measured: Time of Surgery through Year 2
Secondary outcomes (7)
Access-related Complications
Complications associated with the access sites used during treatment and any subsequent unplanned access-related reinterventions. This may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices.
Measured: Time of Surgery through Year 2
Transient Ischemic Attack (TIA)
Transient focal neurological signs or symptoms (lasting <24 h) presumed to be due to focal brain ischemia but without evidence of acute infarction by neuroimaging or pathology (or in the absence of imaging)
Measured: Time of Surgery through Year 2
Life Threatening Bleed
An event leading to either diagnosed hypovolemic shock, required four or more packed red blood cell units or directly led to subject death.
Measured: Time of Surgery through Year 2
Upper Extremity Ischemia
Clinically-reported, device-related ischemia not evident at the time of the index procedure with CTA-verified branch vessel compromise (i.e., malperfusion)
Measured: Time of Surgery through Year 2
False Lumen Status - Treated Segment
Status of the false lumen within the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis.
Measured: Time of Surgery through Year 2
False Lumen Status - Untreated Segment
Status of the false lumen outside of the segment of the aorta initially treated with an endovascular stent graft. It is divided in patent, partial thrombosis and complete thrombosis.
Measured: Time of Surgery through Year 2
False Lumen Perfusion
Flow into the false lumen via Type IA entry flow, Type IB entry flow, Type II entry flow and Type R entry flow.
Measured: Time of Surgery through Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start20 Feb 2025
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507865
- Sponsor's protocol ID
- TGR 23-02TB
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data to be shared will be pseudo-anonymized with subject names and birthdates removed.
Publications
Yamanouchi D, Khashram M, Gable D, Milner R, Yeung KK, Resch TA, Bockler D, Delaney C, Azizzadeh A, Shimamura K, Qasabian R, Han S, Feito Y, Trimarchi S. Real-world data on aortic endografts: Gore Together aortic registry protocol. Front Cardiovasc Med. 2026 Aug 28;13:1803528. doi: 10.3389/fcvm.2026.1803528. eCollection 2026.
PubMed 42729155