Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

May 5, 2025 updated by: W.L.Gore & Associates

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
  • Denmark
      • Copenhagen, Denmark, 2100
  • Germany
      • Dresden, Germany, 01307
        • Suspended
        • Universitätsklinikum Carl Gustav Carus Dresden
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • University of Heidelberg
      • Kiel, Germany, 24105
      • Muenster, Germany, 48149
        • Active, not recruiting
        • Universitatsklinikum Munster
  • Greece
      • Athens, Greece, 106 76
        • Recruiting
        • Evangelismos General Hospital
        • Contact:
      • Athens, Greece, 11527
        • Active, not recruiting
        • Laiko General Hospital of Athens
  • Italy
      • Bologna, Italy, 40138
        • Active, not recruiting
        • Policlinico di Sant'Orsola
      • Brescia, Italy, 25123
      • Genova, Italy, 16132
      • Padova, Italy, 35128
      • Selargius, Italy, 09047
        • Not yet recruiting
        • Azienda Ospedaliera "G. Brotzu"
        • Contact:
  • Netherlands
  • Spain
      • Vigo, Spain, 36312
        • Withdrawn
        • Complejo Hospitalario Universitario de Vigo
      • Zaragoza, Spain, 50009
        • Active, not recruiting
        • Hospital Universitario Miguel Servet
  • Sweden
      • Malmö, Sweden, 205 02
        • Active, not recruiting
        • Skåne University Hospital
  • United Kingdom
      • London, United Kingdom, SE1 7EH
      • London, United Kingdom, W2 1NY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GORE® TAG® Thoracic Branch Endoprosthesis
Patients treated with the TBE Device
Device: GORE® TAG® Thoracic Branch Endoprosthesis
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.
Other Names:
  • TBE device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deployment Technical Success
Time Frame: Time of Surgery
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.
Time of Surgery
Lesion-related Mortality
Time Frame: Day 30 through Year 2

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.
Day 30 through Year 2
Lesion Rupture (treated area)
Time Frame: Time of Surgery through Year 2
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Time of Surgery through Year 2
Lesion Enlargement (treated area)
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
Endoleaks (Type I-V)
Time Frame: Time of Surgery through Year 2
Perfusion of a treated lesion identified through imaging analysis.
Time of Surgery through Year 2
Device Migration
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
Loss of Aortic / Branch Patency
Time Frame: Time of Surgery through Year 2
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Time of Surgery through Year 2
Stroke
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
Paraplegia
Time Frame: Time of surgery through Day 30
New onset spinal cord injury rendering a subject non-ambulatory.
Time of surgery through Day 30
Paraparesis
Time Frame: Time of surgery through Day 30
New onset spinal cord injury causing a minor motor deficit of the lower extremities.
Time of surgery through Day 30
New Onset Renal Failure
Time Frame: Time of surgery through Day 30
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for > 4 weeks.
Time of surgery through Day 30
Renal Function Deterioration
Time Frame: Time of surgery through Year 2
New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.
Time of surgery through Year 2
Device Integrity Events
Time Frame: Time of Surgery through Year 2
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis.
Time of Surgery through Year 2
Reintervention
Time Frame: Time of Surgery through Year 2

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.
Time of Surgery through Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access-related Complications
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
Transient Ischemic Attack (TIA)
Time Frame: Time of Surgery through Year 2
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)
Time of Surgery through Year 2
Life Threatening Bleed
Time Frame: Time of Surgery through Year 2
An event leading to either diagnosed hypovolemic shock, required four or more packed red blood cell units or directly led to subject death.
Time of Surgery through Year 2
Upper Extremity Ischemia
Time Frame: Time of Surgery through Year 2
Clinically-reported, device-related ischemia not evident at the time of the index procedure with CTA-verified branch vessel compromise (i.e., malperfusion)
Time of Surgery through Year 2
False Lumen Status - Treated Segment
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
False Lumen Status - Untreated Segment
Time Frame: Time of Surgery through Year 2
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.
Time of Surgery through Year 2
False Lumen Perfusion
Time Frame: Time of Surgery through Year 2
Flow into the false lumen via Type IA entry flow, Type IB entry flow, Type II entry flow and Type R entry flow.
Time of Surgery through Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2025

Primary Completion (Estimated)

April 1, 2031

Study Completion (Estimated)

April 1, 2031

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR 23-02TB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data to be shared will be pseudo-anonymized with subject names and birthdates removed.

IPD Sharing Time Frame

Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.

IPD Sharing Access Criteria

See above

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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