PICCOLO.

Trial name or title	Paclitaxel Coated Balloons for Prevention of Restenosis in Small Arteries Below the Knee Compared to Angioplasty Using Uncoated Balloons
Methods	Randomized controlled trial
Participants	Country: Germany Setting: 5 hospitals Number of participants: 114 Inclusion criteria: Age 18 to 95 years Rutherford classification 3 to 5 Diameter stenosis ≥ 70%, ≥ 15 mm to 150 mm length, up to 2 vessels to be treated Exclusion criteria: Disease associated with life‐expectancy < 18 months Acute thrombus or aneurysm in the index limb/ vessel Doubts in the willingness or capability of the person to allow follow‐up exam
Interventions	Uncoated balloon angioplasty device: Submarine, Ampherion Deep by Invatec DEB device: Submarine, Ampherion Deep by Invatec coated with paclitaxel 3 µg/mm2 Drug used: paclitaxel Vessels treated: below‐knee arteries
Outcomes	Primary: Late lumen loss of the target lesion after 6 months Secondary: Intervention success rate (defined as restenosis < 50%) Restenosis rate (diameter stenosis of ≥ 50% of reference diameter) MLD at 6 months TLR TVR Target limb revascularization Change in Rutherford classification Change in ABI compared to pretreatment if vessels are compressible Hospitalization (extra days due to complications of the index procedure) and hospitalization between the follow‐up visits due to the index leg Major amputations at the index limb Mortality
Starting date	April 2008
Contact information	Dr Gunnar Tepe, gunnar.tepe@med.uni‐tuebingen.de
Notes	Sponsor: University of Tuebingen, Germany. Industrial support unspecified The status of this trial is unclear. The trial information has not been updated on ClinicalTrials.gov since 2008. Attempts to reach the trial researchers have not been successful