Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Condition(s) studied

Investigational drug(s) / intervention(s)

GORE® TAG® Thoracic Branch Endoprosthesis: Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum.

Study summary

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.

Eligibility

Primary outcome measure(s)

• Deployment Technical Success — Time of Surgery
  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 — Day 30 through Year 2
  Death related to the index endovascular procedure or following conversion to open repair and death related to 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) — Time of Surgery through Year 2
  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) — Time of Surgery through Year 2
  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 (Type I-V) — Time of Surgery through Year 2
  Perfusion of a treated lesion identified through imaging analysis.
• Device Migration — Time of Surgery through Year 2
  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 — Time of Surgery through Year 2
  No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.
• Stroke — Time of Surgery through Year 2
  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 either persists for \> 24 hours or until death or symptoms lasting \< 24 hours, with pathology or neuroimaging confirmation of CNS infarction.
• Paraplegia — Time of surgery through Day 30
  New onset spinal cord injury rendering a subject non-ambulatory.
• Paraparesis — Time of surgery through Day 30
  New onset spinal cord injury causing a minor motor deficit of the lower extremities.
• New Onset Renal Failure — Time of surgery through Day 30
  New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks.
• Renal Function Deterioration — Time of surgery through Year 2
  New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.
• Device Integrity Events — Time of Surgery through Year 2
  wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis.
• Reintervention — Time of Surgery through Year 2
  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 (19)

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