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 Type
OBSERVATIONAL
Enrollment
1,500
TEVAR - thoracic endovascular aortic repair
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGIndiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGCentre Hospitalier Universitaire Strasbourg
Strasbourg, France
RECRUITINGUniversitatsmedizin Frankfurt
Frankfurt, Germany
RECRUITINGRegensburg University Hospital
Regensburg, Germany
RECRUITINGLaiko General Hospital of Athens
Athens, Greece
RECRUITINGHospital Universitari de Bellvitge
Barcelona, Spain
RECRUITINGUppsala University
Uppsala, Sweden
RECRUITINGDeployment 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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