Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

Condition(s) studied

Investigational drug(s) / intervention(s)

Endovascular: TEVAR - thoracic endovascular aortic repair

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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
• 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.

Trial sites (37)

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