EFFPac.

Trial name or title	Phase III Multicenter Randomized Controlled Trial to Assess the Effectiveness of Paclitaxel‐coated Luminor Balloon Catheter versus Uncoated Balloon Catheter in the Superficial Femoral and Popliteal Arteries to Prevent Vessel Restenosis or Reocclusion
Methods	Randomized controlled trial
Participants	Country: Germany Setting: 9 German hospitals Number of participants: 172 Inclusion criteria: Age ≥ 18 years Must agree to undergo the 6‐month angiographic and clinical follow‐up at 12 months postprocedure Rutherford classification 2 to 4 De novo stenotic or restenotic lesion or occlusive lesions in the SFA, PA, or both ≥ 70% DS or occlusion Target lesion length: ≤ 15 cm (TASC II A and B) ≥ 1 patent infrapopliteal runoff artery to the foot If the index lesion is restenotic, the prior PTA must have been > 30 days prior to treatment in the current study Exclusion criteria: Severely calcified target lesions in the SFA/PA resistant to PTA Previous intervention or surgery in the target vessel Major amputation in the same limb as the target lesion Acute MI within 30 days before the intervention Renal insufficiency with a serum creatinine > 2.0 mg/dL at baseline Platelet count < 50 g/L or > 600 g/L at baseline
Interventions	Uncoated balloon angioplasty device: unspecified DEB device: Luminor 35 Paclitaxel Eluting Peripheral Balloon catheter Drug used: paclitaxel Vessels treated: femoropopliteal arteries
Outcomes	Primary: Late lumen loss Secondary: Incidence of ≥ 50% restenosis Freedom from TLR and TVR Rutherford class ABI Change in walking distance from baseline QoL, measured using the WIQ and the EQ‐5D
Starting date	April 2015
Contact information	Dr Ulf Teichgräber, Jena University Hospital, Germany Sponsor: University of Jena, Germany
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