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

Primary safety endpoint is a composite of the following MAEs occurring through 30 days:

• Death
• Stroke (excluding transient ischemic attack)
• Paralysis (excludes paraparesis)

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.

Primary effectiveness as measured by the rate of stent-graft patency through 12 months.

Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.

Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.

Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 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.

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.

Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.

Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.

The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.

Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.

Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.

Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).

The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT

The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.

Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss >1,000 cc.

Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.

Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.

Number of transfusions (units) required from the time of implant through hospital discharge.

Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.

Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.