Stents Post-dilation With DCB or POBA in Femoropopliteal Arteries

Inclusion criteria

• . Age ≥18 years;
• . The subject is legally competent and able to understand the information on the study, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the Informed Consent Form (ICF);
• . Rutherford Category 2-4;
• . Target de novo lesion(s) or non-stented restenotic lesion(s) has angiographic evidence of long-term occlusion (by visual estimate ≥10cm) and is amenable to treatment with stents placement;
• . Patients must be able to be treated with DCB or POBA for post-dilation;
• . Target vessel reference diameter is 4.0-7.0 mm (by visual estimate) and able to be treated with available device size matrix;
• . At least one patent native outflow artery to the ankle free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of outflow disease is NOT permitted; treatment of in-flow disease is permitted prior to treatment with stents placement).
• . No other prior vascular interventions (including contralateral limb) within 2 weeks before and/or planned 30 days after the protocol treatment, with the exception of remote common femoral patch angioplasty separated by at least 2 cm from the target lesion;

Exclusion criteria