|Study (Ref.#)||Randomization (DCB:PB)||Center (n)||Region||Identification Number∗||Enrolment Time||Primary Endpoint||Maximum Available Follow-Up (months)|
|Biolux P-I (25)||1:1||5||Austria, Germany||NCT01221610||Oct 2010/Aug 2011||6-month LLL||12|
|FAIR (8)||1:1||5||Germany||NCT01305070||Jan 2010/Nov 2012||6-month BR∗||12|
|FemPac (26)||1:1||2||Germany||NCT00472472||July 2004/Jan 2006||6-month LLL||24|
|IN.PACT SFA (27,30)||2:1||57||Austria, Belgium, Germany, Italy, Switzerland, USA||NCT01175850||Sep 2010/Apr 2011 (Phase I)|
Apr 2012/Jan 2013 (Phase II)
|LEVANT I (28)||1:1||9||Belgium, Germany, USA||NCT00930813||Jun 2009/Dec 2009||6-month LLL||24|
|LEVANT 2 (6)||2:1||54||Austria, Germany, USA||NCT01412541||Jul 2011/Jul 2012||12-month PP†||12|
|PACIFIER (29)||1:1||3||Germany||NCT01083030||Mar 2010/Aug 2011||6-month LLL||24|
|THUNDER (7,31)||1:1:1‡||3||Germany||NCT00156624||Jun 2004/Jun 2005||6-month LLL||60|
Biolux P-I = A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries; DCB = drug-coated balloon; FemPac = Paclitaxel Coated Balloon Catheter for Inhibition of Restenosis in Femoropopliteal Arteries; FAIR = Randomized Femoral Artery In–Stent Restenosis; IN.PACT SFA = The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population; LEVANT I = A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Catheter vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries With and Without Stenting; LEVANT 2 = A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries; LLL = late lumen loss; PACIFIER = Paclitaxel-coated Balloons in Femoral Indication to Defeat Restenosis; PB = plain balloon; PP = primary patency; THUNDER = Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries.
↵∗ Assessed by Duplex ultrasonography: peak systolic velocity ratio ≥2.4 ∼ ≥50% luminal reduction.
↵† The third group of the THUNDER trial (paclitaxel diluted in the contrast media) was not included in the study.
↵‡ PP was the composite of freedom from clinically driven target lesion revascularization and restenosis as determined by a Duplex ultrasonography–derived peak systolic velocity ratio of ≤2.4.