Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Table 1 Schedule of enrolment, interventions, and assessments

Study period
	Index procedure
	Enrolment		Allocation	Angioplasty	Post-procedure	Follow-up
Timepoint	-t₁^a	-t₂^b	0	Immediately after allocation	Before discharge^§	1-month ± 7 days Phone call	6-month ± 30 days On-site	12-month ± 45 days On-site	24-month ± 60 days On-site	36-month ± 60 days Phone call	48-month ± 60 days On-site	60-month ± 60 days Phone call
Enrolment
Eligibility screen	X
Informed consent	X
Allocation			X
Interventions
Intraluminal guide wire crossing^c		X
Pre-dilation^e		X
Sirolimus-coated balloon angioplasty				X
Paclitaxel-coated balloon angioplasty (control)				X
Assessments
Demographic data	X
Physical examination	X				X		X	X	X		X
Laboratory examination^f	X
Medical history	X
Concomitant medication				X	X	X	X	X	X	X	X	X
Angiography		X		X
Duplex ultrasound^g					X		X	X	X		X
ABI	X				X		X	X	X		X
Rutherford category	X						X	X	X		X
Walking distance (participant self-assessment^h)	X					X	X	X	X	X	X	X
VascuQuol Score	X						X	X	X		X
6-min walk test	X						X	X	X		X
Treadmill test (optional)	X						X	X	X		X
EQ5D-3L index	X					X	X	X	X	X	X	X
AE/SAE				X	X	X	X	X	X	X	X	X

^aAt baseline
^bDuring index procedure
^cSuccessful intraluminal guidewire crossing of the lesion
^dWithin 2 working days after index procedure and before discharge
^ePre-dilation without flow-limiting dissection
^fIncluding pregnancy test were appropriate
^gDUS should also be performed before and after any target vessel revascularization. Adjudication by core laboratory at 6, 12, and 24 months
^hParticipant self-assessment of maximum walking distance should be performed before walk tests and questionnaires
AE adverse event, SAE severe adverse event

ISSN: 1745-6215