JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon

Inclusion criteria

• ✓. Has a Rutherford Clinical Category of 2 - 4.
• ✓. Is willing and capable of complying with all follow-up evaluations at the specified times (including an angiogram at the 1-year follow-up visit).
• ✓. Is ≥ 18 years old.
• ✓. Is able and willing to provide written informed consent prior to study specific procedures.
• ✓. Has evidence at the target lesion of ≥ 70% de novo stenosis of a. ≥ 10 cm length, or b. any chronic total occlusion (\> 1 month by history or known by conventional or CT angiography or arterial duplex ultrasound) in the SFA (at least 1 cm from the bifurcation of the profunda) and/or popliteal artery, or 3. at least grade 2 or higher calcification as defined by the peripheral arterial calcium scoring system (PACCS)26
• ✓. Has evidence of at least one runoff vessel to the ankle/foot of the limb to be treated that does not have significant (\< 70%) stenosis during the index procedure.
• ✓. Has a reference vessel diameter of 4 - 7 mm.
• ✓. Has a target lesion an exchangeable guidewire can cross via the true lumen (without using a re-entry device or a subintimal approach).

Exclusion criteria