GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study

Condition(s) studied

Investigational drug(s) / intervention(s)

GORE® TAG® Thoracic Branch Endoprosthesis: Lesions in aortic arch in Zone 0 or Zone 1

Study summary

A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.

Eligibility

Primary outcome measure(s)

• Number of subjects with index endovascular procedure initiated after (or following) the surgical revascularization procedure — Index Endovascular Procedure Only
  Great vessel surgical revascularization procedure is completed, and the endovascular implantation procedure is initiated for the implantation of the TBE Device, without interim death or study discontinuation.
• Device Technical Success (index procedure only) — Index Endovascular Procedure Only
  * Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. * Patency of the endovascular aortic and side branch components. * The absence of any unanticipated additional corrective procedure related to the device, procedure, or withdrawal of the delivery system.
• Lesion-related mortality — Within 30 days of surgical revascularization or within 30 days of index endovascular procedure
  Death meeting at least one of the following characteristics: * Death during the hospitalization or within 30 days following the surgical revascularization procedure. * Death during the hospitalization or within 30 days following the index endovascular procedure or following conversion to open repair. * Death during the hospitalization or within 30 days following a complication from a secondary procedure associated with the index lesion or study device. * Any death where the treated disease / index lesion or study device caused or significantly contributed to the death, including lesion-rupture, aortic-related complications, disease progression involving the index lesion.
• Disabling Stroke — Within 30 days of surgical revascularization or within 30 days of index endovascular 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: * Is identified within 30-days following the surgical revascularization procedure or within 30-days following the index endovascular procedure -AND- * Persists for ≥ 24 hours or until death, or has symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction -AND- * Has an mRS ≥ 2 with an increase from baseline of at least one grade due to neurological deficits at no more than 120 days post index endovascular procedure.
• Permanent Paraplegia (within 30-days) — Within 30 days of index endovascular procedure
  Paraplegia secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure combined with Spinal Cord Ischemia scale grade = 3 at the one-month follow-up visit. Paraplegia will be assessed using the SVS spinal cord ischemia grading system
• Permanent Paraparesis (within 30-days) — Within 30 days of index endovascular procedure
  Paraparesis secondary to Spinal Cord Ischemia identified within 30 days following the index endovascular procedure, combined with Spinal Cord Ischemia scale grade = 2 at the one-month follow-up visit. Paraparesis will be assessed using the SVS spinal cord ischemia grading system.
• New onset renal failure (within 30-days) requiring on-going dialysis — Within 30 days of index endovascular procedure
  New onset of sustained renal failure identified within 30 days following the index endovascular procedure, combined with requiring dialysis at the 1-Month follow-up visit.
• Lesion rupture (treated area) — Minimum of 60 months and up to a maximum 120 months
  Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or CT / CTA scan.
• Loss of aortic or branch patency — Minimum of 60 months and up to a maximum of 120 months
  No flow or contrast detected through the implanted aortic component or endovascular branch component confirmed with imaging and/or direct observation.
• Endoleaks — Minimum of 60 months and up to a maximum of 120 months
  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.
• Reintervention — Minimum of 60 months and up to a maximum of 120 months
  Additional surgical or interventional procedure related to the treated disease / index lesion, the study device, or to the treatment / procedure. This may include surgical or interventional treatment for endoleaks, disease progression, procedures on the branch to improve or restore patency, spinal drains for Spinal Cord Injury (SCI) management, or conversion to open surgery. Events will not include access site(s) complications, 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.

Trial sites (18)