The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

Table 1 Schedule of enrollment, interventions and assessments for the EffPac trial

	Study period
	Enrollment	Allocation	Post allocation			Close-out
Time point^a	−t ₁	0	t ₁	t ₂	t ₃	t _x
Enrollment:
Prescreening	X
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions:
Intervention DEB catheter			X
Control group POBA catheter			X
Assessments^b:
List baseline variables: XA/DSA				X	X	X
Duplex ultrasound (DUS)				X	X	X
Freedom from TLR/TVR				X	X	X
Rutherford stage				X	X	X
ABI				X	X	X
WIQ				X	X	X
EQ-5D				X	X	X
AE				X	X	X
SAE				X	X	X
Primary endpoint: LLL				X
Secondary endpoints: Occurrence of restenosis				X	X	X
Freedom of TLR				X	X	X
Freedom of TVR				X	X	X
Change of Rutherford				X	X	X
Change of ABI				X	X	X
Patency (DUS)				X	X	X
Change of QoL (WIQ and EQ-5D)				X	X	X
Amputation rate				X	X	X
Dropouts				X	X	X
Mortality				X	X	X

^a− t ₁ screening and enrollment, t ₁ baseline (visit 0), t ₂ follow-up 1 after 6 months (visit 1), t ₃ follow-up 2 after 12 months (visit 2), t _x close-out = end of follow-up 2
^b ABI Ankle-brachial Index, AE adverse events, DEB drug-eluting balloon, DSA digital subtraction angiography, LLL late lumen loss, POBA plain old angioplasty balloon, QoL quality of life, SAE serious adverse events, TLR target lesion revascularization, TVR target vessel revascularization, US ultrasound, WIQ Walking Impairment Test, XA X-ray angiography

ISSN: 1745-6215