An observational study in Vascular Disease, Dissection and Dissection Aortic Aneurysm, sponsored by W.L.Gore & Associates. Recruiting at 37 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by W.L.Gore & Associates · Observational
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.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Compared within Aortic Dissection, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient is age ≥ 18 years at time of signature.
Exclusion Criteria:
Patient is currently enrolled in or plans to enroll in any concurrent drug and/or investigational device study* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Endovascular
Device: Endovascular
TEVAR - thoracic endovascular aortic repair
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.
Time frame: Index Procedure
Lesion-related Mortality
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.
Time frame: From time of index procedure through 10 years of follow-up
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.
Time frame: Through 10 years post-procedure
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.
Time frame: Through 10 years post-procedure
Endoleaks
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
Time frame: Through 10 years post-procedure
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.
Time frame: Through 10 years post-procedure
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.
Time frame: Through 10 years post-procedure
Stroke (All, Serious, Non-Serious)
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
Time frame: Through 10 years post-procedure
Paraplegia (within 30 days of index procedure)
New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure
Time frame: Within 30 days of index procedure
Paraparesis (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
Time frame: Within 30 days of index procedure
New onset renal failure (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
Time frame: Within 30 days of index procedure
Renal function deterioration
New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
Time frame: Within 30 days of index procedure
Device integrity events (e.g., fracture, kinking, compression)
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
Time frame: Through 10 years post-procedure
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.
Time frame: Through 10 years post-procedure
Access-related complications
Complications associated with the access sites used during treatment that may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices.
Time frame: Intra-operatively
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)
Time frame: Through 10 years post-procedure
New Dissection
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.
Time frame: Through 10 years post-procedure
False Lumen Status - treated segment
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.
Time frame: Through 10 years post-procedure
False Lumen Status - untreated segment
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.
Time frame: Through 10 years post-procedure
False Lumen Perfusion
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)
Time frame: Through 10 years post-procedure
Health Economic and Quality of Life Data Analysis
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.
Time frame: Through 10 years post-procedure
Plan to share: No
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