Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease (ARTEMIS Trial)
* Prospective, multi-center, randomized, controlled comparison study * A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions. * Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year. * Patients will be followed clinically for 2 years after the procedure.
• Age 19 years or older
• Symptomatic peripheral artery disease:
‣ Moderate or severe claudication (Rutherford category 2 or 3)
⁃ Critical limb ischemia (Rutherford category 4 or 5)
• Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
• Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
• Patients with signed informed consent