Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). |
|
24 months |
|
Secondary |
Rate of MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). |
|
6 months, 12 months |
|
Secondary |
Rate of all-cause death |
|
6 months, 12 months, 24 months |
|
Secondary |
Rate of target-vessel myocardial infarction (TVMI) |
|
6 months, 12 months, 24 months |
|
Secondary |
Rate of target-vessel target vessel revascularization (TVR) |
|
6 months, 12 months, 24 months |
|
Secondary |
Symptoms of angina and quality of life assessed by the score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L) |
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
Symptoms of angina and quality of life assessed by score of the Seattle Angina Questionnaire (SAQ) |
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. |
6 months, 12 months, 24 months |
|
Secondary |
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of Seattle Angina Questionnaire (SAQ). |
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
Correlation of ?vFFR with score of Seattle Angina Questionnaire (SAQ). |
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. |
6 months, 12 months, 24 months |
|
Secondary |
Correlation of post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). |
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
Correlation of ?vFFR with score of EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). |
The EQ-5D-5L scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) for significant prediction of MACE |
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for ?vFFR useful for prediction of MACE |
MACE defined as all-cause death, target-vessel myocardial infarction (TVMI) and target vessel revascularization (TVR). |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median SAQ score. |
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. vFFR values are within the range 0-1, where higher values indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for post-percutaneous coronary intervention (PCI) vessel fractional flow reserve (vFFR) useful for prediction of higher than median EQ-5D-5L score. |
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. vFFR values are within the range 0-1, where higher values indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for ?vFFR useful for prediction of higher than median SAQ score. |
The SAQ provides results for 6 categories. The patient can receive between 0 and 100 points in each category, where 100 represents the best score. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the optimal cutoff point for ?vFFR useful for prediction of higher than median EQ-5D-5L score. |
The scale asses the patient's self-rated health in five categories (each category 1-5) - higher values indicate worse performance. Additionally, the patient fulfill vertical visual analog scale from 0 to 100, where higher scores indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
Rate of revascularization of any vessel due to exacerbation of angina symptoms. |
Decisions on the performance of revascularization will be made by the attending physician according to the clinical features and available methods. |
6 months, 12 months, 24 months |
|
Secondary |
Rate of definite and probable stent thrombosis. |
|
6 months, 12 months, 24 months |
|
Secondary |
Rate of clinically driven invasive coronary angiography due to exacerbation of angina symptoms. |
Decisions on the performance of invasive coronary angiography will be made by the attending physician according to the clinical features. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the value of in-stent vFFR gradient in predicting the rate of MACE |
vFFR values are within the range 0-1, where higher values indicate better function. |
6 months, 12 months, 24 months |
|
Secondary |
AUC for the value of 3-vessel post-PCI vFFR burden (sum of the vFFR estimated in the three main epicardial arteries) in predicting the rate of MACE |
3-vessel post-PCI vFFR will be defined as the sum of the post-PCI vFFR values derived for each vessel (left anterior descending, circumflex, right coronary artery). |
6 months, 12 months, 24 months |
|