Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Mortality |
Rate of all-cause mortality |
30-day |
|
Secondary |
Mortality |
Rate of all-cause mortality |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Mortality |
Rate of aortic related mortality |
30-day, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Major Adverse Events |
Rate of patients who are free from Major Adverse Events (MAEs) (new permanent disabling stroke (mRS = 2 and at baseline mRS < 2), new permanent (> 30 days) paraplegia or paraparesis, reintervention (excluding reoperation for bleeding or planned or unplanned additional intervention), all-cause mortality) |
12 months |
|
Secondary |
Device technical success |
Rate of patients with device technical success |
24 hours |
|
Secondary |
Procedural success |
Rate of patients with procedural success |
At discharge, an avarage of 30 days |
|
Secondary |
Treatment success |
Rate of patients with treatment success |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Aortic rupture |
Rate of patients with aortic rupture |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Additional intervention |
Rate of patients with planned or unplanned additional intervention |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Reintervention |
Rate of patients with reintervention |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Disabling stroke |
Rate of patients with new disabling stroke |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Paraplegia |
Rate of patients with new permanent (> 30 days) paraplegia |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Paraparesis |
Rate of patients with new permanent (> 30 days) paraparesis |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Renal failure |
Rate of patients with renal failure requiring permanent (> 90 days) dialysis or hemofiltration in a patient with a normal pre-procedure serum creatinine level |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Aortic regurgitation |
Rate of patients with increase in aortic regurgitation grade of greater than 1 compared to pre-operative measurement |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Stenosis |
Rate of patients with stenosis in the supra-aortic head vessels (0 - 30 %, >30 % - 50 %, > 50 % - 70%, > 70%) |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Patency |
Rate of patients with patent supra-aortic head vessels |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Migration |
Rate of patients with retrograde migration > 10 mm of the distal end of the stented part of E-vita OPEN NEO |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Integrity |
Rate of patients with failure of integrity of the E-vita OPEN NEO |
At discharge, an avarage of 30 days, 3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak type Ib (aneurysm) |
Rate of patients with aneurysm that have an endoleak type Ib |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak type II (aneurysm) |
Rate of patients with aneurysm that have an endoleak type II |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak type III (aneurysm) |
Rate of patients with aneurysm that have an endoleak type III |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak type IV (aneurysm) |
Rate of patients with aneurysm that have an endoleak type IV |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Increasing aortic diameter |
Rate of patients with aneurysm that have an increasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT |
12, 24, 36, 60 months |
|
Secondary |
Stable aortic diameter |
Rate of patients with aneurysm that have a stable maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT |
12, 24, 36, 60 months |
|
Secondary |
Decreasing aortic diameter |
Rate of patients with aneurysm that have a decreasing maximum aortic diameter in the stented region (E-vita OPEN NEO) compared to first post-operative CT |
12, 24, 36, 60 months |
|
Secondary |
Endoleak type Ib (dissection) |
Rate of patients with dissection that have an endoleak type Ib |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak II (dissection) |
Rate of patients with dissection that have an endoleak type II |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Endoleak type R (dissection) |
Rate of patients with dissection that have an endoleak type R |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Increasing or stable true lumen size |
Rate of patients with increasing (= 5 mm) or stable true lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Stable or decreasing false lumen size |
Rate of patients with stable or decreasing (= - 5 mm) false lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Obliterated false lumen in stented region |
Rate of patients with obliterated false lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Completely thrombosed false lumen in stented region |
Rate of patients with completely thrombosed false lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Partially thrombosed false lumen in stented region |
Rate of patients with partially thrombosed false lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Patent false lumen in stented region |
Rate of patients with patent false lumen in the stented region |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Obliterated false lumen between stent and celiac trunk |
Rate of patients with obliterated false lumen between the bottom of the stent and the celiac trunk |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Completely thrombosed false lumen between stent and celiac trunk |
Rate of patients with completely thrombosed false lumen between the bottom of the stent and the celiac trunk |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Partially thrombosed false lumen between stent and celiac trunk |
Rate of patients with partially thrombosed false lumen between the bottom of the stent and the celiac trunk |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Patent false lumen between stent and celiac trunk |
Rate of patients with patent false lumen between the bottom of the stent and the celiac trunk |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Obliterated false lumen between celiac trunk and aortic bifurcation |
Rate of patients with obliterated false lumen between the celiac trunk and the aortic bifurcation |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Completely thrombosed false lumen between celiac trunk and aortic bifurcation |
Rate of patients with completely thrombosed false lumen between the celiac trunk and the aortic bifurcation |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Partially thrombosed false lumen between celiac trunk and aortic bifurcation |
Rate of patients with partially thrombosed false lumen between the celiac trunk and the aortic bifurcation |
3-6, 12, 24, 36, 60 months |
|
Secondary |
Patent false lumen between celiac trunk and aortic bifurcation |
Rate of patients with patent false lumen between the celiac trunk and the aortic bifurcation |
3-6, 12, 24, 36, 60 months |
|