Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Deployment Technical Success |
Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system. |
Time of Surgery |
|
Primary |
Lesion-related Mortality |
Death related to the index endovascular procedure, secondary procedure associated with the index lesion or the registry device, or any death where the treated disease / index lesion or registry device caused or significantly contributed to the death |
Day 30 through Year 10 |
|
Primary |
Lesion Rupture |
Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan |
Time of Surgery through Year 10 |
|
Primary |
Lesion Enlargement |
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 CTA scans |
Time of Surgery through Year 10 |
|
Primary |
Endoleaks |
Perfusion of a treated lesion identified through imaging analysis |
Time of Surgery through Year 10 |
|
Primary |
Device Migration |
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. |
Time of Surgery through Year 10 |
|
Primary |
Loss of aortic / branch patency |
No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation. |
Time of Surgery through Year 10 |
|
Primary |
New onset renal failure |
New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for > 4 weeks |
Time of Surgery through Day 30 |
|
Primary |
Renal function deterioration |
New onset of a decrease in eGFR > 30% following treatment when compared to baseline eGFR. |
Time of Surgery through Day 30 |
|
Primary |
Device integrity events |
wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis |
Time of Surgery through Year 10 |
|
Primary |
Reintervention |
Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure. |
Time of Surgery through Year 10 |
|
Secondary |
Characterization of remote data collection to supplement follow-up activities |
An exploratory description intended to assign significance to an increasingly used method of participant engagement to assess utilization, frequency by time, outcomes, contribution to total follow-up, need for elevation of care |
Time of Surgery through Year 10 |
|
Secondary |
New onset buttock claudication / erectile dysfunction |
Patient reported |
Time of Surgery through Year 1 |
|