Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance (TGR 23-02TA)

May 11, 2026 updated by: W.L.Gore & Associates
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

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 Locations

  • Denmark
  • France
  • Germany
      • Frankfurt, Germany
      • Regensburg, Germany, D-93053
        • Recruiting
        • Regensburg University Hospital
        • Contact:
        • Principal Investigator:
          • Fiona Rohllfs, Prof
      • Ulm, Germany, D-89081
  • Greece
  • Italy
      • Milan, Italy
  • Spain
      • Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
        • Principal Investigator:
          • Elena Iborra Ortega, Dr.
  • Sweden
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Wei Zhou, M.D.
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Ali Azizzadeh, MD
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Sukgu Han, M.D.
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Leland Stanford Junior University
        • Principal Investigator:
          • Kenneth Tran, M.D.
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • MedStar Health, MedStar Washington Hospital Center
        • Contact:
        • Principal Investigator:
          • William Yoon, M.D.
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida - Gainesville
        • Contact:
        • Principal Investigator:
          • Zain Shahid, M.D.
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida
        • Contact:
        • Contact:
        • Principal Investigator:
          • Charles Briggs, M.D.
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
        • Contact:
        • Principal Investigator:
          • William Jordan, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Principal Investigator:
          • Joel Corvera, MD
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland - Baltimore
        • Principal Investigator:
          • Shahab Toursavadkohi, M.D.
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Marc Schermerhorn, M.D.
        • Contact:
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • The Hitchcock Foundation at Dartmouth Hitchcock Medical Center
        • Principal Investigator:
          • Bjoern Suckow, M.D.
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Wilderman, M.D.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Principal Investigator:
          • Mark Farber, M.D.
        • Contact:
        • Contact:
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Chad Hughes, M.D.
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals - Cleveland Medical Center
        • Principal Investigator:
          • Jae-Sung Cho, M.D.
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Thomas Jefferson University
        • Contact:
        • Principal Investigator:
          • Cecillia Chin, M.D.
      • Philadelphia, Pennsylvania, United States, 19104
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor Research Institute
        • Principal Investigator:
          • Dennis Gable, M.D.
        • Contact:
      • Plano, Texas, United States, 75075
        • Recruiting
        • Columbia Medical Center of Plano
        • Principal Investigator:
          • Edic Stephanian, M.D.
        • Contact:
    • Utah
      • Murray, Utah, United States, 84157
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Jane He, M.D.
    • Virginia
      • Norfolk, Virginia, United States, 23437
        • Recruiting
        • Sentara Medical Group, Sentara Norfolk General Hospital
        • Principal Investigator:
          • Animesh Rathore, M.D.
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98195
        • Not yet recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Sara Zettervall, M.D.
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin
        • Contact:
        • Principal Investigator:
          • Courtney Morgan, M.D.

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

The target registry population is patients who are treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL at participating sites. This includes initial procedures and reinterventions (regardless of original intervention).

Description

Inclusion Criteria:

  1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
  2. Patient has been or is intended to be treated with an eligible registry device.*

  3. Patient is age ≥ 18 years at time of informed consent signature.

    • The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.

Exclusion Criteria:

  1. 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.
  2. Patient with exclusion criteria required by local law.

  3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

    • The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).

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
Aneurysm/Other Isolated Lesion
Device: Endovascular
TEVAR - thoracic endovascular aortic repair
Dissection
Device: Endovascular
TEVAR - thoracic endovascular aortic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deployment Technical Success
Time Frame: Index Procedure
  • 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.
Index Procedure
Lesion-related Mortality
Time Frame: From time of index procedure through 10 years of follow-up

Death meeting at least one of the following characteristics:

  • Death within 30 days of the index procedure or following conversion to open repair.
  • Death within 30 days following 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.
From time of index procedure through 10 years of follow-up
Lesion Rupture (treated area)
Time Frame: Through 10 years post-procedure
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
Through 10 years post-procedure
Lesion Enlargement (treated area)
Time Frame: Through 10 years post-procedure
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.
Through 10 years post-procedure
Endoleaks
Time Frame: Through 10 years post-procedure

Perfusion of a treated lesion via:

  • Type I endoleak is defined as a sealing failure at one of the attachment zones of the graft to the vessel wall, whereby arterial flow perfuses the treated lesion via a perigraft channel:

    • Type Ia: Proximal aortic attachment zone
    • Type Ib: Distal aortic attachment zone
    • Type Ic: Distal attachment zone for branch component
  • Type II: Retrograde flow from native aortic branch arteries

  • Type III endoleak: Component disconnection or fabric disruption resulting in arterial flow into the perigraft space

    • Type IIIa: Attachment of aortic components (aortic-aortic)
    • Type IIIb: Fabric tear or disruption
    • Type IIIc: Attachment of aortic component-side-branch or side-branch-side-branch
  • Type IV: Late endoleak due to flow through porous fabric
  • Type V/Endotension: Aneurysm sac enlargement > 5 mm with no imaging evidence of an endoleak
  • Indeterminate: Endoleak is identified, but source cannot be ascertained
Through 10 years post-procedure
Device Migration
Time Frame: Through 10 years post-procedure
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.
Through 10 years post-procedure
Loss of aortic / branch patency
Time Frame: Through 10 years post-procedure
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
Through 10 years post-procedure
Stroke (All, Serious, Non-Serious)
Time Frame: Through 10 years post-procedure

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:

  • Persists for > 24 hours or until death -or-
  • Symptoms lasting < 24 hours, with pathology or neuroimaging confirmation of CNS infarction
Through 10 years post-procedure
Paraplegia (within 30 days of index procedure)
Time Frame: Within 30 days of index procedure
New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure
Within 30 days of index procedure
Paraparesis (within 30 days of index procedure)
Time Frame: Within 30 days of index procedure
New onset spinal cord injury causing a minor motor deficit of the lower extremities within 30 days of the index procedure
Within 30 days of index procedure
New onset renal failure (within 30 days of index procedure)
Time Frame: Within 30 days of index procedure
New onset sustained renal failure identified within 30 days of the index procedure, combined with requiring dialysis for > 4 weeks
Within 30 days of index procedure
Renal function deterioration
Time Frame: Within 30 days of index procedure
New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR.
Within 30 days of index procedure
Device integrity events (e.g., fracture, kinking, compression)
Time Frame: Through 10 years post-procedure

Defined as any of the following:

  • Wire fractures, including stents, hooks, or barbs
  • Stent kinking: Narrowing of the stent graft associated with demonstrable angulation in any of the stent components, with demonstrable flow
  • Disruption/tears in the graft component of the stent graft Stent compression or invagination: Transient or permanent stent-graft collapse following complete device deployment, resulting in an overall reduction in the vessel luminal diameter
Through 10 years post-procedure
Reintervention
Time Frame: Through 10 years post-procedure

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.
Through 10 years post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access-related complications
Time Frame: Intra-operatively
Complications associated with the access sites used during treatment that may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices.
Intra-operatively
Transient Ischemic Attack (TIA)
Time Frame: Through 10 years post-procedure
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)
Through 10 years post-procedure
New Dissection
Time Frame: Through 10 years post-procedure
A new arterial tear either caused by a stent graft, natural disease progression or iatrogenic injury from endovascular manipulation. This can include the propagation, or extension, of a previous dissection that was not present at the time of initial presentation.
Through 10 years post-procedure
False Lumen Status - treated segment
Time Frame: Through 10 years post-procedure

Status of the false lumen within the segment of the aorta initially treated with an endovascular stent graft:

  • Patent: Flow present throughout the entire aortic false lumen (absence of thrombus) on arterial-phase or delayed contrast-enhanced imaging.
  • Partial thrombosis: Thrombus or clot within the aortic false lumen but with a residual patent flow channel on arterial-phase or delayed contrast-enhanced imaging.
  • Complete thrombosis: Complete thrombosis of the aortic false lumen on arterial- and delayed-phase imaging.
Through 10 years post-procedure
False Lumen Status - untreated segment
Time Frame: Through 10 years post-procedure

Status of the false lumen outside of the segment of the aorta initially treated with an endovascular stent graft:

  • Patent: Flow present throughout the entire aortic false lumen (absence of thrombus) on arterial-phase or delayed contrast-enhanced imaging.
  • Partial thrombosis: Thrombus or clot within the aortic false lumen but with a residual patent flow channel on arterial-phase or delayed contrast-enhanced imaging.
  • Complete thrombosis: Complete thrombosis of the aortic false lumen on arterial- and delayed-phase imaging.
Through 10 years post-procedure
False Lumen Perfusion
Time Frame: Through 10 years post-procedure

Flow into the false lumen via:

  • Type IA entry flow: flow between the proximal endograft and aortic wall allowing systemic pressure antegrade flow into the primary entry tear and proximal false lumen
  • Type IB entry flow: distal entry tear adjacent to endograft due to septal fenestration or a new intimal tear at the distal aspect of the stent graft (dSINE) allowing systemic pressure direct flow into the false lumen
  • Type II entry flow: retrograde entry flow through arch vessel branches (innominate, carotid, subclavian) or thoracic bronchial and intercostal arteries into the false lumen
  • Type R entry flow: antegrade entry flow from the true lumen into the false lumen through distal branch fenestrations (uncovered intercostal arteries, visceral or renal arteries, lumbar arteries, iliac branches) or septal fenestrations (excluding SINE)
Through 10 years post-procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Economic and Quality of Life Data Analysis
Time Frame: Through 10 years post-procedure
A Health Economic analysis is planned as part of the clinical registry. Initial analyses will only involve data that is collected within the registry CRFs. The objective of the Health Economic analysis is to understand the short- and long-term healthcare resource use and costs of the treatment(s) studied during the period of the clinical registry. Quality of life will also be evaluated at some sites within the Europe, Middle East and Africa (EMEA) regions and Asia-Pacific (APAC) regions, as applicable, using a standard survey.
Through 10 years post-procedure

Collaborators and Investigators

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

Sponsor

W.L.Gore & Associates

Investigators

  • Principal Investigator: Ali Azizzadeh, M.D., Cedars-Sinai Medical Center
  • Principal Investigator: Timothy Resch, Univ. of CPH - Denmark
  • Principal Investigator: Kazuo Shimamura, Osaka University Hospital - Japan

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)

June 19, 2025

Primary Completion (Estimated)

August 1, 2038

Study Completion (Estimated)

August 1, 2038

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGR 23-02TA (Other Identifier: WL Gore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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