Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Clinical endpoints: Myocardial infarction |
|
10 years |
|
Other |
Clinical endpoints: Target lesion failure |
|
10 years |
|
Other |
Clinical endpoints: Target lesion revascularization |
|
10 years |
|
Other |
Clinical endpoints: Stent thrombosis |
|
10 years |
|
Other |
Clinical endpoints: Cardiac death |
|
10 years |
|
Other |
Clinical endpoints: Non-Cardiac death |
|
10 years |
|
Primary |
Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death. |
Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death. |
6 months |
|
Primary |
Index of adverse vessel wall features |
Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain |
6 months |
|
Secondary |
Optical coherence tomography endpoint: acute malapposition |
|
Baseline |
|
Secondary |
Optical coherence tomography endpoint: acquired malapposition |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: persistent malapposition |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Coverage of jailing struts |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Extra stent lumen (including evaginations) |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Late stent recoil |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: stent fracture |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Ostial strut loss |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Mean neointimal thickness |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Stent strut coverage |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Minimal stent area in segmental analysis |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Minimum scaffold expansion area % |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Segmental area stenosis |
|
Baseline, 6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Healing above calcified plaque |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Healing above lipid plaque |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Acute thrombus on struts |
|
Baseline |
|
Secondary |
Optical coherence tomography endpoint: Late thrombus on struts |
|
6 and 24 months |
|
Secondary |
Optical coherence tomography endpoint: Acute expansion |
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation |
Baseline |
|
Secondary |
Optical coherence tomography endpoint:Late recoil |
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation |
6 and 24 months |
|
Secondary |
Angiographic endpoint: Ostial side branch area stenosis |
|
Baseline, 6 and 24 months |
|
Secondary |
Angiographic endpoint: Ostial side branch acute gain after main vessel stenting |
|
Baseline |
|
Secondary |
Angiographic endpoint: Ostial side branch late loss |
|
6 and 24 months |
|
Secondary |
Angiographic endpoint: Ostial distal main vessel area stenosis |
|
Baseline, 6 and 24 months |
|
Secondary |
Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting |
|
Baseline |
|
Secondary |
Angiographic endpoint: Ostial distal main vessel late loss |
|
6 and 24 months |
|
Secondary |
Angiographic endpoint: Proximal main vessel area stenosis |
|
Baseline, 6 and 24 months |
|
Secondary |
Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting |
|
Baseline |
|
Secondary |
Angiographic endpoint: Proximal main vessel late loss |
|
6 and 24 months |
|
Secondary |
Angiographic endpoint: Minimal luminal area of all segments |
|
Baseline, 6 and 24 months |
|
Secondary |
Procedural endpoints: Procedure time |
From sheath insertion to closure device excluding treatment of other vessels |
Baseline |
|
Secondary |
Procedural endpoints: Contrast use |
|
Baseline |
|
Secondary |
Procedural endpoints: Fluoroscopy time |
|
Baseline |
|