FREERIDE Study.

Trial name or title	Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
Methods	Randomized controlled trial
Participants	Country: Europe and Colombia Setting: 16 European hospitals and 1 Colombian hospital Number of participants: 280 Inclusion criteria: Male or nonpregnant female (> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PA segment (Rutherford classification 2 to 5). Single, multiple, or both de novo occluded, stenotic or reoccluded, restenotic lesion(s) of > 70%, ≤ 15 cm in total length and vessel diameter ≥ 4 mm and ≤ 7 mm (by visual estimation) Signed informed consent and complies with the follow‐up visits Successful wire crossing of lesion At least 1 patent (< 50% stenosis) tibioperoneal runoff vessel Exclusion criteria: Gastrointestinal bleeding or coagulopathy contraindicating use of antiplatelet therapy Known intolerance contraindications to study medications and contrast agents, noncontrollable with medication Actively participating in another device or drug study History of hemorrhagic stroke within 3 months Previous or planned surgical or intervention procedure within 30 days of index procedure Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured Acute or subacute thrombus in target vessel Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon) Instent restenosis or prior surgery of the target lesion Abdominal aortic aneurysm ≥ 4 cm diameter
Interventions	Uncoated balloon angioplasty device: unspecified DEB device: Freeway balloon catheter Drug used: paclitaxel 3 µg/mm2 Vessels treated: femoropopliteal arteries
Outcomes	Primary: Rate of clinically driven TLR Secondary: Technical success Clinical success Procedural success ABI improvement Change in Rutherford classification Walking improvement Rate of minor and major complications Rate of TLR Late lumen loss Patency rate
Starting date	May 2011
Contact information	Beatriz Fernandez, fernandez@eurocor.de Rembert Pogge von Strandmann, pogge@eurocor.de
Notes	Sponsor: Eurocor GmbH