RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers

Condition(s) studied

Investigational drug(s) / intervention(s)

RelayPro: Endovascular treatment with investigational device.

Study summary

Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

Eligibility

Primary outcome measure(s)

• Rate of Major Adverse Events (MAEs) — 30 days
  Primary safety endpoint is a composite of the following MAEs occurring through 30 days: * Death * Stroke (excluding transient ischemic attack) * Paralysis (excludes paraparesis)
• Technical success — 24 hours
  Primary effectiveness rate as measured by the technical success through 24 hours, defined as: * Successful delivery of the device through the vasculature; * Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.
• Stent graft patency — 12 months
  Primary effectiveness as measured by the rate of stent-graft patency through 12 months.
• Aneurysm rupture — 12 months
  Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.
• Absence of Type I and III endoleak through 12 months; — 12 months
  Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.
• Absence of stent fractures in the attachment zone through 12 months — 12 months
  Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.
• Absence of open or endovascular secondary interventions — 12 months
  Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.
• Absence of aneurysm expansion (> 5 mm diameter increase) — 12 months
  Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.
• Absence of stent-graft migration — 12 months
  Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT.

Trial sites (35)

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