|
Study period
|
---|
Enrollment
|
Allocation
|
Post allocation
|
Close-out
|
---|
Time point
|
−t1
|
0
|
t1
|
t2
|
t3
|
t4
|
tx
|
Enrollment:
| | | | | | | |
Eligibility screen
|
X
| | | | | | |
Informed consent
|
X
| | | | | | |
Allocation
| |
X
| | | | | |
Interventions:
| | | | | | | |
Intervention CS
| | |
X
| | | | |
Intervention BMS
| | |
X
| | | | |
Assessments:
|
CTA
|
X
| | |
X
|
X
|
X
| |
EQ-5D-5 L
|
X
| | |
X
|
X
|
X
| |
SF-36
|
X
| | |
X
|
X
|
X
| |
Cost-effectiveness
|
X
| | |
X
|
X
|
X
| |
SAE
| | | |
X
|
X
|
X
|
X
|
Mortality
| | | |
X
|
X
|
X
|
X
|
- −t1 = screening and enrollment, t1 = endovascular-stent placement, t2 = 6 months, t3 = 12 months, t4 = 24 months after intervention, tx = end of follow-up at 24 months
- BMS bare-metal stent, CS covered stent, CTA computed tomography angiography, SAE serious adverse event, SF-36 36-item Short Form Health Survey