Total of all reporting groups

The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status.

The Rutherford Clinical Category assessment was missing for 1 Paclitaxel-coated Balloon patient and for 1 Bare Balloon patient.

The Ankle-Brachial Index (ABI) is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease.

The ABI is part of the most missed assessments at baseline which accounts for the missing data. For some participants, ABI is non-measurable or the number too high suggesting non-compressible vessels (with a pressure cuff) and thus cannot be reported.

For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites.

For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).

For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites.

For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).

For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites.

For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).

Diameter stenosis is calculated as the difference between the minimal luminal diameter (MLD) from the target reference vessel diameter (RVD), divided by the RVD, and multiplied by 100 to get the percentage of stenosis. The RVD is typically calculated by averaging the MLD of the healthy part of the vessel both proximal and distal to the vessel lesion

For 3 Paclitaxel-coated Balloon subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites.

For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on available images (All other baseline lesion characteristics are missing).

For 3 DCB subjects, the Core Laboratory considered the treated area as 1 lesion instead of 2 lesions as reported by the sites.

For 1 lesion, the Core Laboratory could only assess lesion location and calcification based on avalaible images (All other baseline lesion characterics are missing).

The lesions characterics are reported as analyzed by angiographic core laboratory by quantitative angiography.

Body mass index (BMI) is a measure of body fat based on height and weight that applies to adult men and women.

BMI data was not available for 4 participants in the Paclitaxel-coated balloon group.

Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.

Bare Percutaneous Transluminal Angioplasty Balloon Catheter

The primary safety endpoint was freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 12 months post-procedure.

Subjects with de novo occluded/stenotic or re-occluded/restenotic lesions will be randomly assigned to treatment with a Paclitaxel-coated balloon or bare balloon.

Bare Percutaneous Transluminal Angioplasty Balloon Catheter