Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

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 through 12 months post-procedure.

Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months

Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.

Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.

Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.

Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.

Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.