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 2 Study overview of published RCTs applying paclitaxel-coated DEB angioplasty in the femoral and popliteal arteries

Study	Author/Journal/Year	Patients	Study device	Primary endpoint	Sponsor
BIOLUX P-I [11]	Scheinert D, JET 2015	60	Biotronik Passeo-18 LUX	LLL 6 mo	Biotronik
DEBATE-SFA [12]	Liistro F, JACC 2013	104	Medtronic IN.PACT Admiral	binary restenosis 12 mo	Independent
DEBELLUM [13]	Fanelli F, JCV 2014	50	Medtronic IN.PACT Admiral or IN.PACT Amphirion	LLL 6 mo	Independent
FemPac [3]	Werk M, CIRC 2008	117	PACCOCATH	LLL 6 mo	Independent
IN.PACT SFA [14, 15]	Tepe G, CIRC 2015; Laird J, JACC 2015	331	Medtronic IN.PACT Admiral	pP 12 mo	Medtronic
LEVANT 1 [8]	Scheinert D, JACC 2014	101	Bard Lutonix DCB	LLL 6 mo	Bard
LEVANT 2 [16]	Rosenfield K, NEJM 2015	476	Bard Lutonix DCB	pP 12 mo	Bard
PACIFIER [5]	Werk M, CIRC 2012	85	Medtronic IN.PACT Admiral	LLL 6 mo	Independent
THUNDER [4, 17]	Tepe G, NEJM 2008, JACC 2015	154	PACCOCATH	LLL 6 mo	Bavaria Medizintechnologie, Schering

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