Acotec DCB Post Market Clinical Follow-up

All Comers Post Market Clinical Follow-up to Continue the Surveillance of the Acotec Drug Coated PTA Catheter Orchid, Tulip and Litos in Lower Limb Treatment

All-comers, prospective, multi-center, single-arm, non-interventional post market clinical follow-up (PMCF) Cohort 1 - Claudicants: Rutherford Clinical Category (RCC) 2-3 Cohort 2 - Critical Limb Ischemia: Rutherford Clinical Category (RCC) 4-6

To prospectively collect and assess safety and efficacy data on the AcoArt drug-coated PTA balloon catheters carrying the CE Mark per current Instructions for Use in a real-world cohort of patients with symptomatic arterial disease undergoing endovascular lower limb revascularization per the institution's standard practice.

Inclusion Criteria:

• 1. Patient is ≥ 18 years old at the time of consent.
• 2. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in iliac, superficial femoral, popliteal and/or infra-popliteal arteries suitable for angioplasty per operator visual assessment.
• 3. Lesion(s) can be treated with available AcoArt Orchid (0.035"), AcoArt Tulip (0.018") and AcoArt Litos (0.014") DCB device per current IFU.
• 4. Subject has provided written informed consent prior to participation in the PMCF, understands the purpose of this PMCF and agrees to comply with all protocol-specified examinations and follow-up appointments.
• 5. Rutherford Classification Category 2-6 Subjects with Rutherford Category 2 have gone through a conservative therapy without success.
• 6. Inflow lesion treated prior to target lesion treatment

Exclusion Criteria:

• 1. Rutherford Classification Category 0, 1
• 2. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints
• 3. Inability to tolerate required antithrombotic or antiplatelet therapies.
• 4. Non-dilatable severely calcified lesion.
• 5. Known hypersensitivity/allergy to components of the investigational device
• 6. Un-treated acute or subacute thrombus in the target lesion.
• 7. Life expectancy < 1 year.
• 8. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
• 9. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
• 10. Myocardial infarction or stroke within 30 days prior to index procedure.