Advance 18PTX Balloon Catheter Study.

Trial name or title	Advance® 18PTX® Balloon Catheter Study: Treatment of Lesions in Superficial Femoral Artery/Popliteal Artery with a Paclitaxel‐coated Balloon.
Methods	Randomized controlled trial
Participants	Country: Germany and Russia Setting: 3 hospitals in Germany and 1 hospital in Russia Number of participants: 150 Inclusion criteria: Age > 18 years Able to provide informed consent Has at least 1 de novo or restenotic lesion(s) with > 70% stenosis documented angiographically of the SFA or PA. If > 1 lesion requires intervention, only 1 should be treated as a study lesion Exclusion criteria: Significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure Lack of at least 1 patent runoff vessel with < 50% stenosis throughout its course Lesions in target area requiring atherectomy (or ablative devices), cutting balloons, cryoplasty balloons, or any other advanced device to facilitate angioplasty balloon or stent delivery
Interventions	Uncoated balloon angioplasty device: Advance® 18LP catheter DEB device: Advance 18PTX catheter Drug used: paclitaxel
Outcomes	Primary: Late lumen loss. Secondary: No information provided on secondary outcomes
Starting date	October 2008
Contact information	None provided
Notes	Sponsor: Cook