NCT06658730 · W.L.Gore & Associates
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
(TGR 23-02TA)
What this study is about
An observational, forward-looking 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.
View original scientific description
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.
Interventions
DEVICE
Endovascular
TEVAR - thoracic endovascular aortic repair
Primary outcome measures
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.
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.
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.
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.
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
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.
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.
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
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
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
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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
- 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 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).
Where
- Tucson, Arizona
- Los Angeles, California
- Stanford, California
- Washington D.C., District of Columbia
- Gainesville, Florida
- Tampa, Florida
- Augusta, Georgia
- Indianapolis, Indiana
- Baltimore, Maryland
- Boston, Massachusetts
- Lebanon, New Hampshire
- Hackensack, New Jersey
And 10 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2026 · Source of record for eligibility and locations