Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta, Aneurysm Thoracic, Aneurysm Dissecting, Transection Aorta, Intramural Hematoma
Conditions
Keywords
Endovascular, CTAG, Post-market Registry, Observational, Multi-regional, Real world data, Together Registry, Gore Together Registry, Gore Together Aortic Registry, Conformable Thoracic Stent Graft, TGR 23-02TA, TGR23-02TA, GORE TAG
Brief summary
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
DEVICEEndovascular
TEVAR - thoracic endovascular aortic repair
Sponsors
W.L.Gore & Associates
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paraparesis (within 30 days of index procedure) | 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 |
| Deployment Technical Success | 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 | 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) | 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) | 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 | 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 | 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 | 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) | 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) | Within 30 days of index procedure | New onset spinal cord injury rendering a subject non-ambulatory within 30 days of the index procedure |
| New onset renal failure (within 30 days of index procedure) | 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 | 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) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access-related complications | Intra-operatively | Complications associated with the access sites used during treatment that may include pseudoaneurysm, hematoma, thrombosis, or complications associated with percutaneous closure devices. |
| Transient Ischemic Attack (TIA) | 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) |
| New Dissection | 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. |
| False Lumen Status - treated segment | 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. |
| False Lumen Status - untreated segment | 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. |
| False Lumen Perfusion | 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) |
Countries
Denmark, France, Germany, Greece, Spain, Sweden, United States
Contacts
CONTACTAshley Hoedt, MS
CONTACTMegan Warner
PRINCIPAL_INVESTIGATORAli Azizzadeh, M.D.
Cedars-Sinai Medical Center
PRINCIPAL_INVESTIGATORTimothy Resch
Univ. of CPH - Denmark
PRINCIPAL_INVESTIGATORKazuo Shimamura
Osaka University Hospital - Japan
Outcome results
None listed